FDA.reportPublic FDA data

COBAS AMPLICOR HIV-1 Monitor Test, version 1.5

Primary DI
00875197000993
Brand
COBAS AMPLICOR HIV-1 Monitor Test, version 1.5
Company
Roche Molecular Systems, Inc.
Model
2
Catalog number
03155935018
Published
2014-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MTLMONITOR,TEST,HIV-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTLMonitor,Test,Hiv-1Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197000993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197000993008751970009938751970009930875197000993

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 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 human immunodeficiency virus 1 (HIV1) nucleic acid 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
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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
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07613336206362cobas® 8800 system09575146001095751460012026-03-26
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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
008171690248803D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMTL2023-01-10
00608337000016OraQuick Advance Rapid HIV 1/2 Antibody TestOrasure Technologies, Inc.MTL2014-09-05
00608337000009OraQuick Advance HIV 1/2 Kit ControlsOrasure Technologies, Inc.MTL2014-09-05
20608337000010OraQuick Advance Rapid HIV 1/2 Antibody TestOrasure Technologies, Inc.MTL2014-09-05