FDA.reportPublic FDA data

cobas® Respiratory 4-flex

Primary DI
00875197007541
Brand
cobas® Respiratory 4-flex
Company
Roche Molecular Systems, Inc.
Model
10586524190
Catalog number
10586524190
Published
2026-02-24
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
QOFMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243455000cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc.2025-07-31QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197007541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197007541008751970075418751970075410875197007541

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus 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 virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
071674100
Device count
1
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
00819704020074FINDER InstrumentBaebies, Inc.QOF2026-05-01
00819704020425FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.QOF2026-05-01
00819704020463FINDER Cleaning AccessoryBaebies, Inc.QOF2026-05-01
00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCQOF2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
14053228039409QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
00884999049369Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049376Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049383Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00875197006285cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007299cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007305cobas liat SARS-CoV-2, Influenza A/B & RSV control kitRoche Molecular Systems, Inc.QOF2025-05-28
00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10810031720016Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)LIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019033TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17