Home› India› Ministry of Health and Family Welfare› PCR Kits approved for testing of Covid-19 as on 09.12.2021...
Date: 2021-12-09 Category: Not Applicable State: Union Government Country: India

PCR Kits approved for testing of Covid-19 as on 09.12.2021

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

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Executive Summary & Key Takeaways

What it means

  • The gazette notification lists PCR kits approved for testing of Covid-19 as of December 9, 2021.
  • The list includes the name of the firm, type of kit (PCR), country of origin, and any approvals (e.g., CE, USFDA).

Key Changes

  • A total of 235 PCR kits from various firms have been approved for Covid-19 testing.
  • The approved kits originate from various countries, including the USA, South Korea, China, Germany, Spain, UK, and others.
  • Some kits are indigenous, manufactured within India.
  • Approvals include CE, USFDA, and NIV Pune.
  • M/S Molbio Diag. Pvt Ltd Truenat Beta is approved as a screening PCR test and not for confirmatory test

Impact Analysis

Stakeholders

  • Kit Manufacturers: Lists manufacturers whose kits have been approved for usage in India.

Suggested Action Items

  • Diagnostic firms should take note of the approval status of M/S Molbio Diag. Pvt Ltd Truenat Beta.

Key Entities Referenced

Roche Diagnostic, Mumbai: Firm based in Mumbai, manufacturing PCR kits from USA S.D Biosensor, Delhi: Firm based in Delhi, manufacturing PCR kits from South Korea with CE approval Matrix, Chennai: Firm based in Chennai, manufacturing PCR kits from China with CE approval Siemens Healthcare Pvt. Ltd.: Firm manufacturing PCR kits from South Korea with CE approval Mylab, Pune: Indigenous firm based in Pune with PCR kits approved by NIV Pune CE: European Conformity marking indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area USFDA: United States Food and Drug Administration NIV Pune: National Institute of Virology, Pune M/S Molbio Diag. Pvt Ltd Truenat Beta: Indigenous firm whose PCR test is approved as a screening test and not for confirmatory test
Official Source Record View Original Source →
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PCR Kits approved for testing of Covid-19 as on 09.12.2021 S. Name of the Firm Type Country No 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 198. 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 19Ltd 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 1935. 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 1949. 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 1964. 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 1976. 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 1988. 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 19100. 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 19112. 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 19124. 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 19136. 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 19148. 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 19160. 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 19171. 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 19RT 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 19193. 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 19210. 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 LLP, InfectID-COVID-19 Corporation, Canada 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 19228. 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 Page 19 of 19

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