PRODUCT EVALUATION STATUS RT PCR KIT, CARTRIDGE BASED PCR, NUCLEIC ACID EXTRACTION KITS, VTM/UTM, and NPS/OPS

Updated as of March 08, 2021

Polymerase Chain Reaction (PCR) Kits
Polymerase Chain Reaction (PCR) Kits
NoProduct NameManufacturerSTATUS
1Argene SARS-COV-2 R-GeneBiomerieux SAPENDING
Waiting for Delivery of Samples
2GENEPRO SARS-CoV2 RT-PCR Detection KitGencurix, Guro-gu, Seoul, KoreaEvaluation Reports Prepared for Release to FDA
3Wantai SARS CoV2 RT-PCR Kit fromBeijing Wantai Biological Pharmacy Enterprise Co., LtdEvaluation Reports Prepared for Release to FDA
4LabGun Covid 19 RT PCR test KitLabgenomics Co. Ltd, Gyeonggi-do, Korea 13488Evaluation Reports Prepared for Release to FDA
5KimForest SARS-CoV-2 Detection Kit V1 and V2KimForest Enterprise Co., Ltd.PENDING
Waiting for Delivery of Samples
6virella SARS-CoV-2 seqc RT-PCR KitGerbion GmbH & Co. KG. Remsstr. 1, 70806 Kornwestheim, GermanyEvaluation Reports Prepared for Release to FDA
7Zybio-SARS-CoV2 (PCR Fluorescent Probe Method)Zybio, IncON HOLD
Product Sample Replacement
8Direct DetectTMSARS-CoV-2 Detection KitCoyote Bioscience Co., Ltd.For Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
9Cobas SARS-COV-2 and Influenza A/B and Cobas SARS-COV-2 and Influenza A/B Quality Control kitRoche Molecular Syatems, Inc.ON-GOING
Received Product Samples
10Aptima SARS-CoV-2 AssayHologic, IncFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
11Qiastat Respiratory SARS-CoV-2 Panel (Catalog No. 691214)QiagenDocuments Received by the Laboratory Research Division
12SML Genetree Ezplex SARS-CoV-2 FAST G KitSML Genetree Co., Ltd.Documents Received by the Laboratory Research Division
13Sansure Biotech Inc/Sansure IponaticSansure Biotech, IncDocuments Received by the Laboratory Research Division
14Real Time RT-PCR Kit for Novel Coronavirus 2019-nCoVShenZhen Uni-Medica Technology Co., Ltd.Documents Received by the Laboratory Research Division
Nucleic Acid Extraction Kits
Nucleic Acid Extraction Kits
NoProduct NameManufacturerSTATUS
1Zybio Inc., SARS Cov 2 Nucleic Acid Detection KitZybio IncFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
2Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Flourescence Probing)Jiangsu CoWin Biotech Co., Ltd.For Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
3Magnetic Based Nucleic Acid (DNA/RNA) Extraction Kit from Diagnostika Pilipinas Inc.Wuxi NEST Biotechnology Co., LtdFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
4BIOER-Magabio Plus Virus RNA Extraction Kit II
Cat. No. BSC87S1E
Hangzhou Bioer TechnologyFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
5Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Flourescence Probing)Jiangsu CoWin Biotech Co., Ltd.For Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
Viral Transport Media and Swabs
Viral Transport Media and Swabs
NoProduct NameManufacturerSTATUS
1CITOSWAB Mini-tipCitotest Labware Manufacturing Co., Ltd.For Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
2CITOSWAB Virus Collection and Transport Kits (VTM-N)Citotest Labware Manufacturing Co., Ltd.For Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
3BIOER - VTM/UTMHangzhou Bioer TechnologyFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
4Biobase VTMBiobase Bio Industry (Shandong) Co., Ltd.For Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
5COPAN VTM-N
COPAN Italia SPAFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
6Disposable Virus Sampling KitZhuhai Lituo Biotechnology Co., Ltd.For Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
7Vincen Disposable Transport Tube with swabAnhui Wnesheng Materials Medical Co., LtdFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
8Biocomma YMJ-TE5 -VTMBiocomma LtdFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
9Biocomma YMJ-TE11 -VTMBiocomma LtdFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
10Biocomma YMJ-SW01E -VTMBiocomma LtdFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office
11Biocomma YMJ-SW11E -VTMBiocomma LtdFor Payment of Evaluation Fee and Schedule of Delivery of Samples to be coordinated by LRD Office