Home GUDID 00875197007497 cobas BV/CV
Primary DI 00875197007497
Brand cobas BV/CV
Company Roche Molecular Systems, Inc.
Model 09988815190
Catalog number 09988815190
Published 2026-09-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name PQA Vaginitis and bacterial vaginosis nucleic acid detection system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00875197007497 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00875197007497 00875197007497 875197007497 0875197007497
GMDN Terms# Term, Definition table Term Definition Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of pathogens associated with vaginitis and/or vaginosis in a clinical specimen, using a nucleic acid technique (NAT). Pathogens intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.
Regulatory Flags# DUNS number 071674100 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00875197007480 cobas BV/CV Control Kit 09988807190 09988807190 2026-09-28 07613336175934 Digital LightCycler Partitioning Engine 09224777001 09224777001 2026-09-24 07613336175941 Digital LightCycler Analyzer 09274804001 09274804001 2026-09-24 07613336231098 Opulus Lymphoma Precision 10257873001 10257873001 2026-05-08 00875197006476 cobas® HBV/HCV/HIV-1 Control Kit 09040773190 09040773190 2021-12-10 00875197004014 cobas® TaqScreen MPX Control Kit, v2.0 2.0 05965390190 2015-02-20 00875197001068 COBAS® AmpliScreen HCV Test, v2.0 2 03302563018 2014-09-17 00875197001099 COBAS® AmpliScreen HIV-1 Test, v1.5 2 03322114018 2014-09-09 00875197001662 cobas® TaqScreen MPX Test 04584252190 04584252190 2014-09-17 00875197002102 COBAS® AmpliScreen HBV Test 03599779190 03599779190 2014-09-17 00875197004045 cobas® TaqScreen MPX Test, v2.0 2.0 05969484190 2015-02-20 07613336206355 cobas® 6800 system 09575154001 09575154001 2026-03-26 07613336206362 cobas® 8800 system 09575146001 09575146001 2026-03-26 00875197007459 cobas® Liat Transfer Pipette Pack 10383852190 10383852190 2026-03-26 00875197005240 cobas® Cdiff Test 06768237190 06768237190 2026-02-24 00875197005288 cobas® 4800 Cdiff Controls and Cofactor Kit 06768300190 06768300190 2026-02-24 00875197006056 cobas® TV/MG 08017450190 08017450190 2026-02-24 00875197006063 cobas® TV/MG Positive Control Kit 07948689190 07948689190 2026-02-24 00875197006377 cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit 09211128190 09211128190 2026-02-24 00875197006742 cobas SARS-CoV-2 09408592190 09408592190 2026-02-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00875197007480 cobas BV/CV Control Kit Roche Molecular Systems, Inc. PQA 2026-09-28 15420045517059 Aptima® Hologic, Inc. PQA 2024-12-19 15420045517066 Aptima® Hologic, Inc. PQA 2024-12-19 15420045517073 Aptima® Hologic, Inc. PQA 2024-12-19 15420045517080 Aptima® Hologic, Inc. PQA 2024-12-19 00382904439767 BD Vaginal Panel on BD COR System BECTON, DICKINSON AND COMPANY PQA 2024-04-02 00382904439255 BD Molecular Swab Collection Kit BECTON, DICKINSON AND COMPANY PQA 2024-02-26 30382904439256 BD Molecular Swab Collection Kit BECTON, DICKINSON AND COMPANY PQA 2024-02-26 07332940007072 Xpert® CEPHEID PQA 2022-04-13 07332940008345 Xpert® CEPHEID PQA 2022-04-12 15420045512023 Aptima® Hologic, Inc. PQA 2019-07-02 15420045512030 Aptima® Hologic, Inc. PQA 2019-07-02 15420045512047 Aptima® Hologic, Inc. PQA 2019-07-02 15420045512054 Aptima® Hologic, Inc. PQA 2019-07-02 15420045512061 Aptima® Hologic, Inc. PQA 2019-07-02 15420045512078 Aptima® Hologic, Inc. PQA 2019-07-02 15420045512085 Aptima® Hologic, Inc. PQA 2019-07-02 15420045512092 Aptima® Hologic, Inc. PQA 2019-07-02 00382904437121 BD MAX™ Vaginal Panel BECTON, DICKINSON AND COMPANY PQA 2017-03-23