Cobas BKV, Cobas EBV/BKV Control Kit, Cobas Buffer Negative Control Kit

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna

Roche Molecular Systems, Inc.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Bkv, Cobas Ebv/bkv Control Kit, Cobas Buffer Negative Control Kit.

Pre-market Notification Details

Device IDK202215
510k NumberK202215
Device Name:Cobas BKV, Cobas EBV/BKV Control Kit, Cobas Buffer Negative Control Kit
ClassificationNucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
ContactRita Hoady
CorrespondentRita Hoady
Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
Product CodeQMI  
CFR Regulation Number866.3183 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-06
Decision Date2020-09-02

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.