PRODUCT EVALUATION STATUS POLYMERASE CHAIN REACTION (PCR) KITS

Updated as of April 26, 2021

No.Product NameManufacturerSTATUS
1Argene SARS-COV-2 R-GeneBiomerieux Inc.PENDING
2SARS-CoV-2 Nucleic Acid Detection Kit
(32T/Kit) 4080101 and (96T/kit) 4080102
Zybio Inc.,PENDING
Please wait for email instructions
3KimForest SARS-CoV-2 Detection Kit V1 and V2KimForest Enterprise Co., Ltd.PENDING
Please wait for email instructions
4Primerdesign - Genesig Covid-19 2G Real-time PCR (CE IVD)Primerdesign LTDPENDING
Please wait for email instructions
5Allplex SARS-CoV-2 ASSAYSeegene Inc.PENDING
Please wait for email instructions
6Direct DetectTMSARS-CoV-2 Detection KitCoyote Bioscience Co., Ltd.PENDING
Please wait for email instructions
7Aptima SARS-CoV-2 Assay
PRO - 06419
Hologic, IncPENDING
Please wait for email instructions
8Diagnostic Kit for Novel-Coronavirus (2019 NCOV) RNA (PCR-Fluorescent Probe Assay)
U20225
USTAR Biotechnologies, Hangzhou Ltd.PENDING
Please wait for email instructions
9SML Genetree Ezplex SARS-CoV-2 FAST G KitSML Genetree Co., Ltd.PENDING
For completion of requirements
10Sentinel STAT-NAT COVId-19 MULTI (in vials)
Sentinel DiagnosticsPENDING
Please wait for email instructions
11AITbiotech abTES qPCR KitAIT Biotech PTE, LTDPENDING
Please wait for email instructions
12Sansure Biotech Inc/Sansure IponaticSansure Biotech, IncPENDING
Please wait for email instructions
13Real Time RT-PCR Kit for Novel Coronavirus 2019-nCoVShenZhen Uni-Medica Technology Co., Ltd.PENDING
Please wait for email instructions
14BD SARS-CoV-2 Reagent Kit and Consumables (Catridge Based PCR)
SG 1701
BD (Bcton Dickinson)PENDING
Please wait for email instructions
15Opti SARS-CoV-2 RT PCR Test Kit
99-57003; 99-57004
Optimedical System, Inc., Georgia, USAPENDING
Please wait for email instructions
16Zybio SARS-CoV-2 Nucleic Acid Detection Kit (96T/kit) 4080102Zybio, Inc. Chiongqing, ChinaPENDING
Please wait for email instructions
17Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR FLorescent Probe Method)Zybio, Inc. Chiongqing, ChinaPENDING
Please wait for email instructions
18Zeesan SARS-CoV-2 Test Kit (RT PCR)Xiamen Zeesan Biotech Co., Ltd.PENDING
For completion of requirements
19Novel Corona Virus 2019-nCoV Rapid Detection Kit (LAMP)Shanghai GeneSc Biotech Co., Ltd., Shanghai, ChinaPENDING
Please wait for email instructions
20AQ-TOP COVID-19 Rapid Detection Kit plus
SS-9040
SeaSun Biomaterials Inc.PENDING
Please wait for email instructions
21U-TOP COVID-19 Detection Kit Plus
SeaSun Biomaterials Inc.PENDING
Requirements received atLaboratory Research Division Office