FDA.reportPublic FDA data

cobas CMV

Primary DI
00875197004922
Brand
cobas CMV
Company
Roche Molecular Systems, Inc.
Model
07001029190
Catalog number
07001029190
Published
2017-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PABCytomegalovirus (cmv) dna quantitative assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PABCytomegalovirus (Cmv) Dna Quantitative AssayMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197004922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197004922008751970049228751970049220875197004922

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) in a clinical specimen, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336231098Opulus Lymphoma Precision10257873001102578730012026-05-08
00875197006476cobas® HBV/HCV/HIV-1 Control Kit09040773190090407731902021-12-10
00875197004014cobas® TaqScreen MPX Control Kit, v2.02.0059653901902015-02-20
00875197001068COBAS® AmpliScreen HCV Test, v2.02033025630182014-09-17
00875197001099COBAS® AmpliScreen HIV-1 Test, v1.52033221140182014-09-09
00875197001662cobas® TaqScreen MPX Test04584252190045842521902014-09-17
00875197002102COBAS® AmpliScreen HBV Test03599779190035997791902014-09-17
00875197004045cobas® TaqScreen MPX Test, v2.02.0059694841902015-02-20
07613336206355cobas® 6800 system09575154001095751540012026-03-26
07613336206362cobas® 8800 system09575146001095751460012026-03-26
00875197007459cobas® Liat Transfer Pipette Pack10383852190103838521902026-03-26
00875197005240cobas® Cdiff Test06768237190067682371902026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor Kit06768300190067683001902026-02-24
00875197006056cobas® TV/MG08017450190080174501902026-02-24
00875197006063cobas® TV/MG Positive Control Kit07948689190079486891902026-02-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit09211128190092111281902026-02-24
00875197006742cobas SARS-CoV-209408592190094085921902026-02-24
00875197006759cobas SARS-CoV-2 Quality Control Kit09408835190094088351902026-02-24
00875197006902cobas® TV/MG09040633190090406331902026-02-24
00875197006919cobas® TV/MG Positive Control Kit09040641190090406411902026-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999051065Alinity mABBOTT MOLECULAR INC.PAB2024-02-22
15420045514553Aptima®Hologic, Inc.PAB2022-06-01
15420045514560Aptima®Hologic, Inc.PAB2022-06-01
15420045514577Aptima®Hologic, Inc.PAB2022-06-01
15420045514584Aptima®Hologic, Inc.PAB2022-06-01
00884999049598Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049604Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049611Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049956Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00875197006421cobas® CMVRoche Molecular Systems, Inc.PAB2021-12-10
00875197006490cobas® CMV Control KitRoche Molecular Systems, Inc.PAB2021-12-10
04053228024538artus® CMV QS-RGQ MDx KitQIAGEN GmbHPAB2018-05-04
00875197004939cobas CMV Control KitRoche Molecular Systems, Inc.PAB2017-07-06
00884999045774RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999045781RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999045798RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999047297RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999046603RealTimeABBOTT MOLECULAR INC.PAB2017-04-17
04053228002086artus® CMV RGQ MDx KitQIAGEN GmbHPAB2017-01-04
00875197002584COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.PAB2014-09-10