PRODUCT EVALUATION STATUS POLYMERASE CHAIN REACTION (PCR) KITS

Updated as of July 30, 2021

NoProduct NameManufacturerStatus
1SARS-CoV-2 Nucleic Acid Detection Kit
4080102
Zybio Inc.,ONGOING
Samples received and ongoing evaluation
2KimForest SARS-CoV-2 Detection Kit V1KimForest Enterprise Co., Ltd.PENDING
To deliver on August 2021
3Primerdesign - Genesig Covid-19 2G Real-time PCR (CE IVD)Primerdesign LTDON HOLD
Please wait for email instruction
4Allplex SARS-CoV-2 ASSAYSeegene Inc.ON HOLD
Samples Delivered/Awaiting for calibration
5Direct DetectTMSARS-CoV-2 Detection KitCoyote Bioscience Co., Ltd.PENDING
Please wait for email instructions and please prepare for delivery
6Aptima SARS-CoV-2 Assay
PRO - 06419
Hologic, IncPENDING
For delivery and payment
7Diagnostic Kit for Novel-Coronavirus (2019 NCOV) RNA (PCR-Fluorescent Probe Assay)
U20225
USTAR Biotechnologies, Hangzhou Ltd.PENDING
Please wait for email instructions
8SML Genetree Ezplex SARS-CoV-2 FAST G KitSML Genetree Co., Ltd.ONGOING
Samples received, for additional requirements
9AITbiotech abTES qPCR KitAIT Biotech PTE, LTDON-HOLD
Please update once product is available
10Sansure Biotech Inc/Sansure IponaticSansure Biotech, IncPENDING
Ongoing evaluation
11Real Time RT-PCR Kit for Novel Coronavirus 2019-nCoV (REF: R030)ShenZhen Uni-Medica Technology Co., Ltd.PENDING
Please wait for email instructions for other requirements
12Opti SARS-CoV-2 RT PCR Test Kit
99-57003; 99-57004
Optimedical System, Inc., Georgia, USAPENDING
Please submit endorsement from FDA
13Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR FLorescent Probe Method)Zybio, Inc. Chiongqing, ChinaPENDING
Please wait for email instructions
14Zeesan SARS-CoV-2 Test Kit (RT PCR)Xiamen Zeesan Biotech Co., Ltd.PENDING
Please wait for email instructions
15Novel Corona Virus 2019-nCoV Rapid Detection Kit (LAMP)Shanghai GeneSc Biotech Co., Ltd., Shanghai, ChinaPENDING
For completion of requirements
16AQ-TOP COVID-19 Rapid Detection Kit plus
SS-9040
SeaSun Biomaterials Inc.PENDING
Please wait for email instructions
17U-TOP COVID-19 Detection Kit Plus
SeaSun Biomaterials Inc.PENDING
Please submit endorsement from FDA
18RADI COVID-19 Detection KitKH Medical Co., LtdPENDING
For completion of requirements
19Uni-medica Real Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N) (REF: R030-02)Shenzhen Uni-Medica Technology Co.PENDING
Please wait for email instructions
20Novel Corona virus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes)_LiferiverLiferiver Bio-Tech (Uniteds States) Corp.PENDING
For completion of requirements
21COVID-19 (SARS-CoV-2) Nucleic Acid Test KitWuhan EasyDiagnosis Biomedicine Co., Ltd.PENDING
For completion of requirements
22Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)Shanghai BioGerm Medical Technology Co., LtdPENDING
For completion of requirements
23LightMix Modular SARS-CoV (COVID-19) E-gene & LightMix Modular SARS-CoV-2 (COVID19) RdRP-geneRoche Molecular Systems, Inc.(Brancburg)PENDING
Please wait for email instructions
24BGI Detection Kit for 6 mutations in S gene of SARS-CoV-2 (ARMS-PCR)BGI PathoGenesis PharmaceuticalPENDING
Please submit endorsement from FDA
25VereRT ZeroPrep COVID-19 PCR Kit (Saliva)Veredus Laboratories Pte. Ltd.qPENDING
Please wait for email instructions
26PCL COVID-19 Speedy RT PCR Detection KitPCL, Inc.PENDING
Please wait for email instructions
27Veri-Q PCR 316 nCOV (QM) Detection KitMiCo BioMed Co., Ltd.
PENDING
Please wait for email instructions
28DA0990 Detection Kit for 2019-nCov FluoresceneDa An Gene Co., Ltd. of Sun Yat-sen UniversityPENDING
Please wait for email instructions
29FTD SARS-CoV-2 (REF:FTD-114-32)Fast Track Diagnostics LuxemborgPENDING
Please wait for email instructions
30TaqPath COVID-19 CE-IVD RT-PCR KitLife Technologies Corporation as part of Thermo Fisher ScientificsPENDING
Please wait for email instructions
31OPTI SARS-COV-2 RT-PCR TestOPTI Medical SystemsPENDING
Please wait for email instructions
32UNI-MEDICA Real Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N, E)Shenzhen Uni-Medica Technology Co., Ltd
Shenzhen, Guangdong Province, P.R China
PENDING
Please wait for email instructions
33Saragene Coronavirus Test KitCoSara Diagnostic Private Limited, Gujarat, IndiaPENDING
Please wait for email instructions
34Vircell SARS-COVVircell SARS-COV-2/FLU/RVS/ Real Time PCR kit-2/FLU/RVS/ Real Time PCR kitVircell S.LPENDING
Please submit endorsement from FDA
35Mollacu Covid 19 Detection Kit
4080101 (32 T/kit) / 4080102 (96 T/kit)
Zybio, Inc.PENDING
Please submit endorsement from FDA