FDA.reportPublic FDA data

cobas liat CT/NG/MG nucleic acid test

Primary DI
00875197007268
Brand
cobas liat CT/NG/MG nucleic acid test
Company
Roche Molecular Systems, Inc.
Model
09449604190
Catalog number
09449604190
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LSLDNA-REAGENTS, NEISSERIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240197000cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.2025-01-16QEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197007268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197007268008751970072688751970072680875197007268

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type sexually transmitted 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 microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

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
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15420045511880Aptima®Hologic, Inc.LSL2023-10-26
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10810031720061Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
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00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYLSL2022-06-08
00884999048898Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00810031720002Visby Medical Sexual Health Click TestVisby Medical, Inc.LSL2021-09-15
00810031720033Visby Medical Power AdapterVisby Medical, Inc.LSL2021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackVisby Medical, Inc.LSL2021-09-15
15420045512832Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045512849Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045512894Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045512900Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045511835AptimaHologic, Inc.LSL2019-09-26
15420045511842AptimaHologic, Inc.LSL2019-09-26
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA AssayBECTON, DICKINSON AND COMPANYLSL2018-05-25
00382904429706BD MAX™ CT/GC/TVBECTON, DICKINSON AND COMPANYLSL2018-05-25