FDA.reportPublic FDA data

cobas® SARS-CoV-2 Qualitative 192T

Primary DI
00875197006841
Brand
cobas® SARS-CoV-2 Qualitative 192T
Company
Roche Molecular Systems, Inc.
Model
09446109190
Catalog number
09446109190
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QQXRespiratory specimen nucleic acid SARS-CoV-2 test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197006841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197006841008751970068418751970068410875197006841

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
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00875197007497cobas BV/CV09988815190099888151902026-09-28
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07613336175941Digital LightCycler Analyzer09274804001092748040012026-09-24
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

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Primary DI, Brand, Company table
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20816101027136Simplexa COVID-19 Positive Control GEN II Pack DIASORIN MOLECULAR LLCQQX2025-09-17
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15420045517004Aptima®Hologic, Inc.QQX2025-03-14
15420045517035Aptima®Hologic, Inc.QQX2025-03-14
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
80190302019438Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR ControlLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
07332940008581GeneXpert®CEPHEIDQQX2024-01-22
00382904453619BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-12-09
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00875197006858cobas® SARS-CoV-2 Qualitative Control KitRoche Molecular Systems, Inc.QQX2023-09-12
00875197006933cobas® SARS-CoV-2 Qualitative 480TRoche Molecular Systems, Inc.QQX2023-09-12
20816101027020Simplexa COVID-19 DirectDIASORIN MOLECULAR LLCQQX2023-06-16
20816101027037Simplexa COVID-19 Positive Control PackDIASORIN MOLECULAR LLCQQX2023-06-16
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00851458005235BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
06973342000530COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-02-02
06973342000158COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-01-30
10789594001002MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
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10789594001101MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001354MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001361MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
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