Home India Ministry of Health and Family Welfare PCR Kits approved for testing of Covid-19 as on 25.01.2023...
Date: 2023-01-25 Category: Not Applicable State: Union Government Country: India

PCR Kits approved for testing of Covid-19 as on 25.01.2023

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification lists PCR kits approved for COVID-19 testing as of January 25, 2023.
  • The list includes the name of the firm, type of kit, and country of origin or manufacturer.

Key Changes

  • The notification lists 272 approved PCR kits for COVID-19 testing.
  • The kits are manufactured by various firms located in India, USA, South Korea, China, Germany, Spain, UK, Turkey, Taiwan, Russia, Singapore, Czech Republic, Japan, Finland, Italy, Denmark, Belarus, Australia, Sweden, Canada, Malaysia and other countries.
  • Several kits are indigenous, while others are manufactured by foreign companies.
  • Some kits have approvals from USFDA or CE for emergency use.

Impact Analysis

Stakeholders

  • Import and Export agencies: Provides a list of approved imported kits.

Suggested Action Items

  • Regularly update the approved list based on new approvals and performance data.

Key Entities Referenced

PCR Kits: Kits used for Polymerase Chain Reaction, a method for detecting the presence of the COVID-19 virus. Roche Diagnostic, Mumbai: A firm listed as having an approved PCR kit of USA origin. S.D Biosensor, Delhi: A firm listed as having an approved PCR kit from M/s. SD Biosensor Korea, CE Approved Matrix, Chennai: A firm listed as having an approved PCR kit from M/s GhangzhouWandfo Biotech Co.Ltd. China, CE Approved Siemens Healthcare Pvt. Ltd.: A firm listed as having an approved PCR kit from M/s. Lab Genomics Co. Ltd., South Korea, CE Approved Mylab, Pune: A firm listed as having an approved Indigenous PCR kit approved by NIV Pune Med Source Ozone: A firm listed as having an approved PCR kit from M/s. Hangzhon Biomedical Pvt. Ltd. Biotechnology Co. Ltd., China, CE Approved Invitrogen Bioservices (Thermofisher): A firm listed as having an approved PCR kit from M/s. Life Technologies, USA, US Approved M/s Altona Diag.Pvt Ltd, Delhi: A firm listed as having an approved PCR kit from M/S Altona Diag. GmbH Germany CE approved M/s Apollo Hospital Enterprise Ltd, Chennai: A firm listed as having an approved PCR kit from M/S Sanscure Biotech Inc China CE approved M/S Cepheid, Delhi: A firm listed as having an approved PCR kit from M/S Cepheid , USA Approved by USFDA FOR EMERGENCY USE M/S Fisher Bio Pharma Services Ahmedabad: A firm listed as having an approved PCR kit from M/S Life Technologies, USA Approved by USFDA and CE for Emergency use M/S Abbott Healthcare Pvt Ltd Inc: A firm listed as having an approved PCR kit from M/S Abbott Molecular USA Approved by USFDA and CE for Emergency use M/S Molbio Diag. Pvt Ltd Goa: A firm listed as having an approved Indigenous Truenat Beta Approved as screening PCR test and not for confirmatory test M/S Vinclan Technologies Pvt Ltd: A firm listed as having an approved PCR kit from M/S Shanghai Fosun Long March Medical Science Co. Ltd, China CE Approved and USFDA(EUA) M/s Parekh Integrated Services Pvt. Ltd. Mumbai: A firm listed as having an approved PCR kit from M/s Quidel Corporation, USA,USFDA(EUA) M /S Agappe Diagnostics Ltd, Ernakulam, Kerala: A firm listed as having an approved Real Time RT – LAMP Indigenous COVID 19 Testing Kit (COVID 19 Test Kit - Isothermal Amplification Method) M /S Cepheid India Private Limited, New Delhi.: A firm listed as having an approved Indigenous Xpert Xpress SARS-CoV-2 RT - PCR M /s Premas Life Sciences Pvt. Ltd, Delhi.: A firm listed as having an approved RT-PCR Assay from M/s Fluidigm Corporation, UK Advanta Dx SARS-CoV-2 M /s Roche Diagnostics India Pvt. Ltd, Mumbai: A firm listed as having an approved RT-PCR assay from M/s. Roche Molecular Systems, Inc, USA Cobas SARS-CoV-2 & Influenza A/B M /s Cepheid India Pvt Ltd, New Delhi: A firm listed as having an approved RT-PCR from M/s Cepheid, USA Xpert Xpress CoV-2/Flu/RSV Plus (RT-PCR) USFDA: United States Food and Drug Administration CE: European Conformity marking NIV Pune: National Institute of Virology, Pune
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PCR Kits approved for testing of Covid-19 as on 25.01.2023 S.No Name of the Firm Type Country of Kit 1. Roche Diagnostic, Mumbai PCR USA 2. S.D Biosensor, Delhi PCR M/s. SD Biosensor Korea, CE Approved 3. Matrix, Chennai PCR M/s GhangzhouWandfo Biotech Co.Ltd. China, CE Approved 4. Siemens Healthcare Pvt. PCR M/s. Lab Genomics Co. Ltd., Ltd. South Korea, CE Approved 5. Mylab, Pune PCR Indigenous approved by NIV Pune 6. Med Source Ozone PCR M/s. Hangzhon Biomedical Pvt. Ltd. Biotechnology Co. Ltd., China, CE Approved 7. Invitrogen Bioservices PCR M/s. Life Technologies, (Thermofisher) USA, US Approved Page 1 of 218. M/s Athenese Dx Pvt. Ltd. PCR M/S CertestBiotec, Chennai Spain CE approved 9. M/s Altona Diag.Pvt Ltd, PCR M/S Altona Diag. Delhi GmbH Germany CE approved 10. M/s Apollo Hospital PCR M/S Sanscure Biotech Enterprise Ltd, Chennai Inc China CE approved 11. M/S Gastro Lab Pune PCR M/S Immunodiagnostic IncGermany CEapproved 12. Soution One Delhi PCR M/S Seegene Inc South Korea CE approved 13. M/S Cepheid, Delhi PCR M/S Cepheid , USA Approved by USFDA FOR EMERGENCY USE 14. M/S Trivitron Healthcare Pvt PCR M/S Shandong Ltd, Chennai Yingsheng Biotechnology Co Ltd , China CE approved 15. M/S Genetix Biotech Asia PCR M/S Primer Design Ltd Pvt Ltd, Delhi , UK CE approved 16. M/s Gland Pharma Ltd , PCR M/S Shanghai Fosum Telangana co Ltd China CE approved 17. M/S Perkin Elmer India PCR M/S Suzhou Sym-Bio Pvt Ltd China CEapproved 18. M/S Fisher Bio Pharma PCR M/S Life Technologies, Services Ahmedabad USA Approved by USFDA and CE for Emergency use 19. M/S Abbott Healthcare Pvt PCR M/S Abbott Molecular Page 2 of 21Ltd Inc USA Approved by USFDA and CE for Emergency use 20. M/S POCT Services Pvt Ltd PCR M/S Zybo Inc, China , Delhi 21. M/S 3i Molecular Solutions, PCR M/s Seegene Inc, Banglore Korea 22. M/S Cosmic Scientific , PCR M/S Getein Biotech Chennai China 23. M/S Inbios India Delhi PCR M/S Sanscure Biotech Inc China CE approved 24. M/S Molbio Diag. Pvt Ltd Truenat Beta Approved as screening Goa PCR test and not for confirmatory test Indigenous 25. M/S Kilpest India Ltd , TruPCR Indigenous Bhopal 26. M/S Imperial Life Sciences PCR M/S BGI Pvt Ltd Biotechnology (Wuhan) co. Ltd China 27. M/S Krishgen Biosystems PCR M/S Kreative Mumbai Technolab USA 28. M/s Cosara Diagnostics Pvt. PCR M/s Co-Diagnostics Inc. Ltd. USA 29. M/s POCT Services Pvt. Ltd PCR M/s MicobiomedCo.Ltd. South Korea 30. M/s POCT Services Pvt. Ltd. PCR M/s YD Diagnostics Corp. South Korea 31. M/s Hemogenomics Pvt. Ltd. PCR M/s PCL Inc. South Bangalore Korea 32. M/s Medsource Ozone PCR Indigenous Biomedicals Pvt.Ltd. 33. M/s Medsmart Logistics Pvt. PCR M/s Sansure Biotech Inc. Ltd. China 34. M/s ADT India Pvt. Ltd. Delhi PCR M/s ADT Biotech SdnMalaysiap Page 3 of 2135. M/s Trivitron Healthcare Pvt. PCR M/s Shanghai ZJ Bio Ltd. Tech. Co. Ltd. China 36. M/s Qiagen India Pvt. Ltd. SARS COV-2 Panel M/s Qiagen GmbH Germany 37. M/S Life Cell International PVT PCR M/S Osang Healthcare Ltd LTD , South Korea 38. M/s Humole Diagnostics Pvt Ltd PCR M/s SeegeneInc,South Korea 39. M/S Krypton Biomedicals Pvt PCR M/s SeegeneInc,South Ltd Korea 40. M/S Aadivighinesh Chem Pvt PCR M/S Dia Carta Inc USA Ltd 41. M/S KDH Biomedical Pvt Ltd PCR M/s Vircell Spain 42. M/s Advy Chemical Pvt Ltd PCR M/S Shanghai ZJ Biotech Mumbai Co. Ltd, China 43. M/S Becton Dickinson India Pvt PCR M/S Gene Ohm Sciences Ltd Canada Inc , Canada 44. M/S Biomeriux India Pvt Ltd PCR M/S Biomeriux S.A France 45. M/S Elder Projects Ltd Thane PCR M/S Sanscure Biotech Inc China CE approved 46. Vinclan Technologies Pvt Ltd PCR M/S Shanghai Fosun Long March Medical Science Co. Ltd, China CE Approved and USFDA(EUA) 47. M/S MDAAC International Pvt PCR M/S Coyote Biosciences Ltd Co. Ltd, China 48. M/s Agappe Diagnostics Ltd Fluorescent PCR M/S Maccuara Biotechnology Ltd China Page 4 of 2149. M/s Parekh Integrated Services PCR M/s Quidel Corporation, Pvt. Ltd. Mumbai USA,USFDA(EUA) 50. M/S KDH Biomedicals Pvt Ltd PCR M/s Dynamiker Mumbai Biotechnology (Tianjin) Co Ltd China 51. M/S BIODX Healthcare New PCR Flourescent Probe M/S Zybio Inc, China Delhi method 52. M/S Bharat Parenterals Ltd PCR M/S Well Bios Inc Vadodara South Korea 53. M/s Namoha Bio Pvt. Ltd. PCR M/S Well Bios Inc New Delhi South Korea 54. M/s Cosara Diagnostics Pvt. PCR Indigenous Ltd. Ahmedabad 55. M/s Rihim Pharma PCR M/s AIT Biotech PTE International LLP, Delhi Ltd. Singapore 56. M/s SirusBiocare Pvt. Ltd. PCR M/s Inbios International Kolkata Inc. USA 57. M/S Horiba India Pvt Ltd PCR M/s Boditech Med Inc South Korea 58. M/S Huwel Lifesciences Pvt PCR Indigenous Ltd,Telangana 59. M/S Cronies Pharma PCR M/S DowGene Co Ltd &Biosciences Pvt Ltd South Korea Telangana 60. M/s Health ARX Technology PCR M/s SolGent Co. Ltd. Pvt. Ltd. Delhi South Korea 61. M/s Invitrogen BioServices PCR M/s Life Technologies India Pvt. Ltd. USA 62. M/S Inbios India Delhi PCR M/S InbiosINTERNATIONAL ,USA 63. M/s Diagnostics Biosystems PCR M/s Advanced (India) Delhi Molecular Diag. UK Page 5 of 2164. M/S Helini Biomolecules PCR Indigenous 65. M/S Meril Diagnostics Pvt Ltd PCR Indigenous 66. M/S Prosper Channel Life PCR M/S Shanghai Fosun Sciences India Pvt Ltd Long March China 67. M/S 365 Medical PCR M/S DNA Technology Research and Production Russia 68. M/S Allied Biotechnology India PCR M/S In-bios Pvt Ltd International USA 69. M/S Biotron Healthcare India PCR M/S AtilaBiosystems Pvt Ltd ,USA 70. M/s Jetta Labs PCR M/S Sansure Biotech Inc China 71. M/s Siemens Healthcare Pvt. PCR M/s Lab Genomics Co, Ltd. Ltd. South Korea 72. M/s Siemens Healthcare Pvt. PCR M/s FastTrack Ltd. Diagnostics Luxembourg 73. M/S KHC Healthcare India Pvt PCR M/S Ltd BioneerCorporation , N. Delhi South Korea 74. M/S BYUNGMAN Electric Pvt PCR M/S Paxgen Bio Co. Ltd Ltd, South Korea Haryana 75. M/S Deep Meditech Pvt Ltd PCR M/S Zybio Inc, China Delhi Page 6 of 2176. M/S Perkin Elmer India Pvt Ltd PCR M/S Wallace Oy, Finland 77. M/S InbiosIndia ,N.Delhi PCR M/S Sentinel S.p.a Italy 78. M/S Alpha Agencies , PCR M/S Intron Karnataka Biotechnology Inc, South Korea 79. M/s Godolo&Godolo Exports PCR M/s RTA, Turkey Pvt. Ltd. 80. M/s Holly Drugs Pvt. Ltd. PCR M/s Wuhan Easydiagnosis, China 81. M/s Lab care Diagnostics, PCR Indigenous India Pvt. Ltd. 82. M/s Biohouse Solutions Pvt. PCR M/s Sentinel S.P.A, Ltd Italy 83. M/S BioGenomics Ltd PCR Indigenous 84. M/s Jaya Surgical & Pharma PCR M/s Sansure Biotech Pvt. Ltd. Hyderabad Inc. China 85. M/s Lab X, Kerala PCR M/s Y.D Diagnostics Corp. South Korea 86. M/s Invitrogen Bioservices PCR M/s Life Technologies India Pvt. Ltd. Corp. USA 87. M/s Cygen Consultancy Pvt. PCR M/s Seegene Inc. Ltd., Imphal South Korea Page 7 of 2188. M/s Bharat Parenterals Ltd., PCR M/s K.H Medical Co. Vadodara Ltd. South Korea 89. M/s CPC Diagnostics Pvt. Ltd. PCR M/s Euroimmune AG Germany 90. M/s Stag Global Pvt. Ltd, PCR M/s Osang Healthcare Co. Ltd. South Korea 91. M/S Innvolution Healthcare PCR M/S General Biologicals Corp, Taiwan 92. M/S Healthcare Pvt Ltd PCR M/S RTA, TURKEY 93. M/s Imperial Life Sciences Pvt PCR M/S PCL Inc, Korea Ltd 94. M/S Shiva Scientific Company PCR M/s BAG Diag. GmbH, Germany 95. M/S Bilcare Ltd PCR M/S BioSewoom Inc South Korea 96. M/S Brinton Pharmaceutical PCR M/S BGI EuropeA/S Ltd Denmark 97. M/S CliniExperts Services Pvt PCR M/S Progenie Molecular Ltd Spain 98. M/S Molbio Diagnostics Pvt Ltd Truenat Indigenous 99. M/S ADT India Pvt Ltd PCR M/S Gene Proof Czech Republic Page 8 of 21100. M /S Kin Diagnostics, Kolkata PCR M/s Kogenebiotech Co Ltd, South Korea 101. M /S Loften India Pvt Ltd PCR M/S INtRON Biotechnology Inc, South Korea 102. M /s Gravity Global Hospitality PCR M/S 1drop Inc South Pvt Ltd Korea 103. M /S POCT Services Pvt Ltd PCR Indigenous 104. M /S Meridian Biotech PCR M/S Seegene Inc South Korea 105. M /S Angstrom Biotech Pvt Ltd PCR Indigenous 106. M /S Kilpest India Ltd PCR Indigenous TRUPCR(V-3.2) 107. M /s. Agappe Diagnostics Ltd, Real Time RT – LAMP Indigenous Ernakulam, Kerala COVID 19 Testing Kit ( COVID 19 Test Kit - Isothermal Amplification Method) 108. M /S Artec Diagnostic System PCR M/S Seasun Biomaterials Inc South Korea 109. M /S Hemogenomics Pvt Ltd PCR M/S Hologic Inc, USA 110. M /S AsvinsLifetechnologies PCR M/S Seasun Pvt Ltd Biomaterials South Korea 111. M /S Topaim Properties Pvt Ltd PCR M/S Shanghai Fosun Long March Medical Science Co Ltd China Page 9 of 21112. M /S GCC Biotech India Pvt Ltd PCR Indigenous 113. M /S Siemens Healthcare Pvt PCR M/S Lab Genomics Co. Ltd Ltd, South Korea 114. M /S Avantor Performance PCR M/S Altona Diagnostics Materials India Ltd GmbH Germany 115. M /s Parekh Integrated PCR M/S Quidal Corp USA Services Pvt Ltd 116. M /S Wockhardt Ltd PCR M/S SNP Biotechnology Turkey 117. M /S Mili Healthcare Pvt Ltd PCR M/S Sansure Biotech Inc China 118. M /S Oscar Medicare Pvt Ltd PCR Indigenous 119. M /S Innvolution Healthcare Pvt PCR M/S General Biologicals Ltd Corp, Taiwan 120. M /S Gene Store India Pvt Ltd Expert SARS-COV-2) Indigenous PCR 121. M /S TrivitronHealthcare Pvt COVID Sure Multiplex RT- Indigenous Ltd PCR 122. Multiplex RT-PCR Indigenous M/S Genes2Me Pvt Ltd 123. M /S Nandan Exports &Imports I copy COVID –qPCR 1drop Inc, South Korea Pvt Ltd Page 10 of 21124. M /S Biorad Laboratories (India) SARS-CoV-2 ddPCR M/S Biorad Pvt Ltd Laboratories USA 125. M /S Becton Dickinson India BD SARS-CoV-2 for BD M/S Gene Ohm PVT Ltd Max –RTPCR Sciences Canada INC, Canada 126. M /S BI Biotech India Pvt Ltd RT-PCR M/S Biocore Co. Ltd , South Korea 127. M /S Karwa Enterprises Pvt Ltd RT-PCR Indigenous 128. M /S Genetix Biotech Asia Pvt RT-PCR M/S BioSewoom Inc Ltd South Korea 129. M /S Medipol Pharmaceutical One step TR-qPCR Indigenous India Pvt Ltd 130. M /S WrigNanosystems Pvt Ltd One step probe freeRT- Indigenous PCR 131. M /S Eurofins Amar Immuno RT-PCR M/S NovaTec Diagnostics Pvt Ltd Immunodiagnostics GbbH, Germany 132. M /S Aspen Laboratories Pvt RT-PCR Indigenous Ltd 133. M /S Siemens Healthcare Pvt LabGunExoFast RT-PCR M/S Lab Genomics CO. Ltd Ltd South Korea 134. M /S Bhatt Biotech India PVT RT-PCR Indigenous Ltd 135. M /S Mylab Discovery Solutions Pathodetect PCR kit Indigenous PVT Ltd Page 11 of 21136. M /S Trivitron Healthcare Pvt Covid Sure Promultiplex Indigenous Ltd RT-PCR Kit 137. T rue Healthcare India Pvt Ltd 1copy qPCR Multikit M/S 1 drop Inc South Korea 138. M /S GCC BIOTECH India Pvt Diagsure(multiplex RT- Indigenous Ltd PCR) 139. M /S Effibar India Pvt Ltd RT-PCR M/s Bioneer Corporation South Korea 140. M /S Perkin Elmer Health RT-PCR M/s Wallace Oy,Finland Sciences, Pvt Ltd 141. M /S BI Biotech India Pvt Ltd DiaPlexQ RT-PCR M/S Solgent Co. Ltd South Korea 142. M /s. POCT Services Private Q-Line RT-PCR Indigenous Limited 143. M /S Vishat Diagnostics Pvt Ltd RT-PCR M/S Shenzhen Unimedica Technology Co Ltd China 144. M /s OSB Agencies Pvt Ltd RT-PCR M/s Medical and Biological Laboratories Co Ltd Japan 145. M /s DSS Imagetech Pvt Ltd RT-PCR M/S Vitros S.A Spain 146. M /S Loften India Pvt Ltd RT-PCR M/S INtRON Biotechnology INC , South Korea 147. M /S Helini Biomolecules RT-PCR Indigenous Page 12 of 21148. M /S Alere Medical Pvt Ltd ID Now Covid-19 M/S Abbott Diagnostics Scarborough Inc USA 149. M /S Achira Labs Pvt Ltd One Tube Multiplex RT- Indigenous qPCR 150. M /s Premas Life Sciences Covid-19 PCR M/s Optolane Technology, South Korea 151. M /s Nucleus Diagnosys Real time PCR Indigenous 152. M /s Molbio Diagnostics Pvt Ltd Chip based Real Time Indigenous Duplex PCR 153. M /S Ubio Biotechnology Covid-19 RTPCR Indigenous System Pvt Ltd 154. M /S AffigenixBiosolutions Pvt One step RT-qPCR Indigenous Ltd 155. M /s Biosystems Diag. Pvt Ltd RT-PCR Indigenous 156. M /s Tata Medical and SARS-COV-2 CRISPR Indigenous Diagnostic Ltd Kit 1.0 157. M /s Athenes Dx Pvt Ltd RT-PCR Indigenous 158. M /S Myotec Surgical Pvt Ltd RT-PCR M/S Optolane Technologies Inc South Korea 159. M /s Wevio Global Pvt Ltd RT-PCR M/s Bioneer Corp South Korea Page 13 of 21160. M /s. Biotime Healthcare Novel Coronavirus M/s Guangdong Ardent Private Limited (COVID-19) Nucleic Acid Biomed Co., Ltd, China Detection Kit (PCR- fluorescent Probe) 161. M /s. NeoDx Biotech Labs CoviDxTM mPlex-4R Indigenous Private Limited, Bangalore SARS-CoV-2 RT-PCR Detection Kit 162. M /s. MD Next Life Sciences ExProbeTM SARS-CoV-2 M/s TBG Biotech LLP, New Delhi. Testing Assay Corp, Taiwan RT – PCR Kit 163. M /s Anjanajyoti Systems Q Sens nCoV 2019 M/s Cancerrop Co. Ltd, Private Limited, New Delhi. Detection Kit South Korea. RT – PCR Kit 164. M /s Shree Venkatesh Medical Real-Time OneStep RT- M/s SolGent Co. Ltd, Agencies, Raipur PCR based assay system South Korea for detection of COVID19 (DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit CV-IVD) 165. M /s Cepheid India Private Xpert Xpress SARS-CoV- Indigenous Limited, New Delhi. 2 RT - PCR 166. M /s. Nandan Exports And 1copy™ COVID-19 qPCR M/s 1drop Inc, South Imports Private Limited, Triplex Kit Korea. Andhra Pradesh. 167. M /s Pontika Aerotech Ltd, One step RT-PCR Indigenous Himachal Pradesh COVID-19 Diagnostic Kit 168. M /s Cosara Diagnostics Novel Coronavirus (2019- Indigenous Private Limited, Gujarat nCoV) V.2 Test Kit RT – PCR Kit 169. M /s Premas Life Sciences Pvt. Advanta Dx SARS-CoV-2 M/s Fluidigm Ltd, Delhi. RT-PCR Assay Corporation, UK 170. M /s Genetix Biotech Asia Pvt. COVISure (Version 2) Indigenous Ltd, Delhi COVID-19 Real Time PCR Kit Page 14 of 21171. M /s Genetix Biotech Asia Pvt. COVISure (Lyo Mix) Indigenous Ltd, Delhi COVID-19 Real Time PCR Kit 172. M /s MOLBIO DIAGNOSTICS Truemix™ COVID-19 Indigenous PVT. LTD, Goa Real Time Duplex PCR Test for COVID-19 173. M /s NeoDx Biotech Labs CoviDx Assure SARS- Indigenous Private Limited, Bangalore CoV - 2 RT-PCR Detection Kit. CoviDx Detect SARS-CoV - 2 RT-PCR Detection Kit 174. M /s EPYGEN BIOTECH GenoCoV One-step Indigenous PRIVATE LIMITED, multiplex RT-PCR kit Maharashtra 175. M /s Metadesign Solutions SARS-COV-2 RT-PCR Indigenous Private Limited, Haryana Detection Kit 176. M /s AB DiagnopathMfg Pvt COVID-19 RT-PCR Kit Indigenous Ltd, Rajasthan 177. M /s Biotime Healthcare Pvt Vazyme - 2019-Novel M/s Nanjing Vazyme Ltd, Gujarat Coronavirus (2019-nCoV) Medical Technology Triplex RT-qPCR Co., Ltd., China Detection Kit 178. M /s Metropolis Healthcare Ltd, ArtTest COVID-19 test kit M/s ArtBioTech LLC, Mumbai – RT-PCR Belarus 179. M /s Invitrogen Bioservices CoviPath™ COVID-19 Indigenous India Private Limited, RT-PCR Kit Bengaluru 180. M /s Invitrogen Bioservices TaqPath™ COVID-19 CE- M/s Life Technologies India Private Limited, IVD RT-PCR Kit Corporation, USA Bengaluru 181. M /s Himedia Laboratories Pvt Hi-PCR® Coronavirus Indigenous Ltd, Mumbai (COVID-19) Multiplex Probe PCR Kit 182. M /s Genetix Biotech Asia Pvt. SMARTCHEK® Novel M/s Genesystem Co., Ltd, Coronavirus (SARS-CoV- Ltd, South Korea Delhi 2) Detection Kit Page 15 of 21RT PCR Kit 183. M /s Transcience Innovative TrueScreenCOVID-19 Indigenous Technologies, Chennai Multiplex Real Time PCR detection Kit 184. M /s Roche Diagnostics India Cobas SARS-CoV-2 & M/s. Roche Pvt. Ltd, Mumbai Influenza A/B Molecular Systems, Inc, USA Multiplex real-time RT- PCR assay 185. M /s Trivitron Healthcare Pvt. COVIDSure Pro Multiplex Indigenous Ltd, Chennai RT PCR Kit 186. M /s SvashmiGenotech Private Stellence Covid 19 RT Q Indigenous Limited, Bangaluru PCR Kit 187. M /s Trivitron Healthcare Pvt. COVIDSure Multiplex RT Indigenous Ltd, Chennai PCR Kit 188. M /s Sidak Life Care Pvt Ltd, Sidak Covid 19 RT-PCR Indigenous New Delhi (SARS-CoV-2 RNA) 189. M /s Genome Diagnostics Pvt Covid-19 Real Time PCR Indigenous Ltd, Delhi (India) - 110058 Kit (Geno-Sen’s nCoV-2019 (RG)) 190. M /s Transasia Bio-Medicals ErbaMDx COVID-19 Real Indigenous Ltd, Time PCR Detection Kit 191. M /s Meril Diagnostics Private Meril One-Step COVID-19 Indigenous Limited, Gujarat RT-PCR Kit (Lyophilized) (Target ORF1ab and N genes) Meril One-Step COVID-19 RT-PCR Kit (Lyophilized) (Target ORF1ab, E and N genes) 192. M /s. KOPRAN STAT-NAT® COVID-19 M/s Sentinel Ch S.P. LABORATORIES LIMITED, HK (RT-PCR) A., Italy Maharashtra Page 16 of 21193. M /s BioGenomics Limited, BioCov-iD-ERN Real Time Indigenous Mumbai RT-PCR kit for detection of Covid-19 194. M /s Vishat Diagnostic Pvt Ltd, SARS-CoV-2 Fluorescent M/s Maccura Mumbai PCR Biotechnology Co. Ltd., China 195. M /s PerkinElmer India Pvt. Ltd, PKamp™ Respiratory M/s Wallac Oy, Finland Chennai SARS-CoV-2 RT-PCR Panel kit 196. M /s QIAGEN India Pvt. Ltd, artus SARS-CoV- 2 Prep& M/s QIAGEN GmbH, Delhi UM Kit (RT-PCR) Germany 197. M /s SNIBE DIAGNOSTIC Molecision SARS-CoV-2 M/s Shenzhen New (India) Private Limited RT-PCR Industries Biomedical Engineering Co., Ltd. China 198. M /s. R-BiopharmNeugen Pvt., VivalyticCoV test (RT- M/s.Bosch Healthcare Ltd, Hyderabad PCR) Solutions GmbH , Germany 199. M /s Thermo Fisher Scientific Accula SARS Cov-2 Test M/s Mesa Biotech Inc, India Pvt. Ltd, Hyderabad (RT-PCR) USA, 200. M /s DIAGNOSTIC CARE AND Molecision SARS-CoV-2 M/s Shenzhen New TRADING PVT LTD, Chennai RT-PCR Industries Biomedical Engineering Co., Ltd., China 201. M /s. R-BiopharmNeugen Pvt., BOSCH Vivalytic SARS- M/s.Bosch Healthcare Ltd, Hyderabad CoV-2 (RT-PCR) Solutions GmbH, Germany 202. M /s BioMerieux India Pvt. Ltd, SARS-COV-2 RESPI R- M/s Biomerieux SA, Rewari, Haryana. GENE (RT-PCR) France 203. M /s PINKTECH DESIGN 96 SARS-CoV-2 Kit (RT- M/s Genedrive PRIVATE LIMITED, New Delhi PCR) Diagnostics Limited, UK 204. M /s Roche Diagnostics India Cobas® SARS-CoV-2 & M/s. Roche Molecular Pvt. Ltd, Mumbai Influenza A/B , RT-PCR Systems, Inc. USA 205. M /s CliniExperts Services Pvt. Cue COVID-19 Test M/s Cue Health Inc., Ltd, New Delhi (isothermal nucleic acid USA amplification) 206. M /s DNA XPERTS PVT LTD, Covid19 PCR Kit Indigenous Vishakpatnam 207. M /s Edif Medical Systems, SARS-Cov-2 Fluorescent M/s Maccura New Delhi PCR Biotechnology Co., Ltd., China 208. M /s POLY MEDICURE POLYMED Q 2019 nCoV Indigenous LIMITED, Delhi RT PCR Kit 209. M /s VIW Vaccine World Private HA TECH SARS-CoV-2 M/s HA TECH PTY Limited, Chennai RT-PCR Multiplex LTD, Australia Diagnostic Kit Page 17 of 21210. M /s MERIDIAN BIOTECH, Allplex™ 2019-nCoV M/s SEEGENE INC, Bengaluru Assay (RT-PCR) South Korea 211. M /s MERIDIAN BIOTECH, Allplex™ SARS-CoV- M/s SEEGENE INC, Bengaluru 2/FluA/FluB/RSV Assay South Korea (RT-PCR) 212. M /s MERIDIAN BIOTECH, Allplex™ SARS-CoV-2 M/s SEEGENE INC, Bengaluru Master Assay South Korea 213. M /s ADT India Pvt. Ltd, LyteStarTM 2019-nCoV M/s ADT Biotech Sdn. New Delhi. RT-PCR Kit 2.0 Bhd, Malaysia 214. M /s Avience Biomedicals Avienbio Covid 19 RT Indigenous Private Limited,Delhi PCR 215. M /s NeoDx Biotech Labs CoviDx DirectPlex SARS- Indigenous Private Limited, Bangalore CoV-2 RT-PCR Detection Kit 216. M /s Abbott Healthcare Pvt. Alinity m SARS-COV-2 M/s Abbott Molecular Ltd., Chennai AMP Kit Inc, USA 217. M /s Shankaranarayana Life SN CoV Ensure: One Indigenous Sciences LLP, Bengaluru Step Multiplex SARS CoV-2 RT-PCR Detection Kit 218. M /s. Acrannolife Genomics RTLAMP Covid Test Kit Indigenous Private Limited, Chennai 219. M /s JJH Ventures Private VERI-Q:COVID-19 M/s Micobiomed Co., Limited, Pune Multiplex Detection Kit Ltd, Republic of Korea (RT-PCR) 220. M /s BIZSOCH MICROBIO-SaarS- M/s Norgen Biotek CONSULTANTS InfectID-COVID-19 Corporation, Canada LLP,Vadodara, Gujarat 221. M /s BIOSCI HEALTH CARE, BioSci true-detect COVID- Indigenous Madhya Pradesh (India) - 19 RT-PCR Test 462010 222. M /s Oscar Medicare Private identi SARS-CoV-2 RT Indigenous Limited, Delhi PCR 223. M /s KARWA ENTERPRISES KARWA COVID-19 RT- Indigenous PRIVATE LIMITED, Delhi LAMP DIAGNOSTIC KIT 224. M /s GENES 2ME PVT. LTD, RT-Direct Multiplex Real Indigenous Gurgaon, Haryana Time PCR Kit for COVID- 19 225. M /s Tata Medical And Tata MD CHECK RT-PCR Indigenous Diagnostics Limited, Flex Chennai. 226. M /s BioSystems Diagnostics Concepta CoViDx RT- Indigenous Pvt. Ltd. Chennai qPCR Kit 227. M /s BioSystems Diagnostics CoviPlus RT-qPCR Kit Indigenous Pvt. Ltd., Chennai Page 18 of 21228. M /s. Agappe Diagnostics Ltd, Direct COVID -19 LAMP Indigenous Kerala Test Kit 229. M /s Vanguard Diagnostics Pvt. QRx Saral Test SARS Indigenous Ltd, New Delhi COV-2 RT - LAMP Kit 230. M /s Tata Medical And Tata MD CHECK RT-PCR Indigenous Diagnostics Limited, Tamil 3Gene Nadu 231. M /s Tata Medical And Tata MD CHECK RT-PCR Indigenous Diagnostics Limited, Tamil FAST Nadu 232. M /s Tata Medical And Tata MD CHECK RT-PCR Indigenous Diagnostics Limited, Tamil Fast 3Gene Nadu 233. M /s Cosara Diagnostics ABC (Influenza A/B, Indigenous Private Limited, Ahmedabad. COVID-19) Multiplex Real-Time PCR Test Kit 234. M /s DNA XPERTS PVT LTD, XPERT COVIDO-19 Indigenous Delhi (India) – 110092. MULTIPLEX RTPCR KIT 235. M /s Huwel Lifesciences Pvt. Quantiplus Multiplex Indigenous Ltd, Telangana (India) - Covid-19 Detection Kit 500075 V2.0 236. M /s Tata Medical And Tata MD CHECK RT-PCR Indigenous Diagnostics Limited @ M/s XF - Covid-19 Kit NeoDx Biotech Labs Pvt Ltd, Bengaluru 237. M /s INDO-MIM Private Limited, RT PCR Test Kit SARS Indigenous (Bangalore) Rural, Karnataka Cov2 (India) - 561203 238. M /s Cepheid India Pvt Ltd, Xpert Xpress CoV- M/s Cepheid AB, New Delhi, Delhi (India) 2/Flu/RSV Plus Sweden 239. M /s Transasia Diagnostics ErbaMDx COVID-19 RT- Indigenous Private Limited, AMTZ PCR Kit Campus, Visakhapatnam, Andhra Pradesh 240. M /s. Humole Diagnostics Allplex :SARS-CoV-2 M/s Seegene Inc., Private Limited, NOIDA, NEPZ Master Assay South Korea , Gautam Buddha Nagar, Uttar Pradesh 241. M /s Tata Medical And Tata MD CHECK RT-PCR Indigenous Diagnostics Limited, Tamil OmiSure (Detection of Nadu (India) Omicron variants) 242. M /s Genetix Biotech Asia Pvt COVISure Media Direct Indigenous Ltd, Delhi (India) - 110015 COVID-19 Real Time PCR Kit 243. M /s Siemens Healthcare SARS-CoV-2 Multiplex Indigenous Private Limited, Vadodara, E/N Gene RTPCR Assay Gujarat (India) Kit Page 19 of 21244. M /s Achira Labs Pvt Ltd, GenePath Dx CoViDelta Indigenous Bengaluru, Karnataka RT-qPCR Kit vME-2 245. M /s Himedia Laboratories Pvt Hi-PCR® COVID-19 Indigenous Ltd, Maharashtra (India) Triplex Probe PCR Kit 246. M /s Vitromed Healthcare, Covid 19 RT PCR Kit Indigenous Jaipur, Rajasthan 247. M /s Roche Diagnostics India cobas® SARS-CoV-2 M/s. Roche Molecular Pvt. Ltd., Maharashtra (India) Nucleic acid test for use Systems, Inc. USA on the cobas® Liat® System 248. M /s Vimek Bioconcept Pvt Ltd, Covid-19 RT PCR Indigenous Maharashtra (India) - 400067 249. M /s Axiva Sichem Biotech, AXIBIO One Step RT- Indigenous Haryana (India) - 131028 PCR Kit for Covid-19 250. M /s. Himedia Laboratories Pvt Hi-PCR® Covid-19 Indigenous Ltd, Maharashtra (India) Detection Kit (Dry Swab Method) 251. M /s Yashraj Biotechnology CoviGene Qualitative RT- Indigenous Limited, Maharashtra PCR for the Detection of SARS-CoV-2 252. M /S Kriya Medical KRIVIDA NOVUS SARS Indigenous Technologies Private Limited, Cov-2 RT-qPCR Tamil Nadu (Omicron) Detection Kit 253. M /s Cepheid India Pvt Ltd, Xpert Xpress CoV- M/s Cepheid, USA New Delhi 2/Flu/RSV Plus (RT-PCR) 254. M /s Mylab Discovery Solutions CoviSwift COVID-19 S Indigenous Pvt. Ltd, Pune, Plus Rapid PCR Kit 255. M /s Alchem Diagnostics, BIOPRO COVID-19 One- Indigenous Coimbatore, Tamil Nadu Step Multiplex RT-PCR Kit 256. M /s Genocare India, Delhi BioGX XfreeTM Covid-19 M/s BioGX Inc, USA Direct RT-PCR 257. M /s Trivitron Healthcare Pvt. COVIDsure DIRECT Indigenous Ltd., Visakhapatnam, Andhra Covid Mutiplex RT-PCR Pradesh kit with extraction free technology 258. M /s Genes2Me Private CoVFlu One Step RTPCR Indigenous Limited, Haryana (India) - Kit (COVID-19 and 122001 Influenza (Flu A and Flu B)) 259. M /s Bajaj Healthcare Ltd. KANEKA Direct RT – PCR M/s KANEKA (Public Ltd) Vadodara, Gujarat kit SARS – CoV - 2 Corporation Osaka (India) Plant, Japan 260. M /s BioGenex Life Sciences COVID-19 TRIPLEX RT- Indigenous Pvt Ltd, Telangana. PCR DIRECT KIT Page 20 of 21261. M /s Promea Therapeutics ProPCR COVID 19 RT- Indigenous Private Limited, Telangana qPCR 262. M /s Achira Labs Pvt Ltd, GenePath Dx CoviSpeedy Indigenous Bengaluru (RT-PCR) 263. M /s Mylab Discovery Solutions PathoDetectTM Multiplex Indigenous Pvt. Ltd. Pune. SARSCoV-2 RT PCR assay 264. M /s GCC BIOTECH INDIA DiAGSure COVID-19 Indigenous PRIVATE LIMITED, West (Omicron variant) TaqMan Bengal, Kolkata RT-PCR Kit 265. M /s GCC BIOTECH INDIA DiAGSure COVID-19 and Indigenous PRIVATE LIMITED, West Fungal Infection TaqMan Bengal, Kolkata PCR Kit 266. M /s Avience Biomedicals Pvt. Avien Covi Quick Covid Indigenous Ltd, UP 19 Hid RTqPCR Assay 267. M /s Abbott Diagnostics ID NOW™ COVID-19 2.0 M/s. Abbott Diagnostics Medical Private Limited, (Isothermal nucleic acid Scarborough, Inc, USA Gurgaon, Haryana (India) amplification technology (NAAT)) 268. M /s QIAGEN India Pvt. Ltd, NeuMoDx™ SARS-CoV-2 M/s. NeuMoDx Delhi (India) - 110025 Test Strip (RT-PCR) Molecular Inc. USA 269. M /s AB Diagnopath Mfg Pvt InnoDete ct CL COVID- Indigenous Ltd, Rajasthan 19 ISO PCR Kit 270. M /s Kamineni Life Sciences KAMINENI SARS-COV-2 Indigenous Private Limited, Hyderabad (COVID-19) RT PCR Kit 271. M /s SOLUTION ONE, Delhi Allplex™ SARS-CoV-2 M/s Seegene Inc, Master Assay South Korea 272. M /s Altona Diagnostics India SARS-CoV-2 Type & FLU M/s. Altona Diagnostics Pvt. Ltd, Delhi RT-PCR Detection Mix 1.5 GmbH, Germany Page 21 of 21

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