FDA.reportPublic FDA data

cobas® 4800 Cdiff Controls and Cofactor Kit

Primary DI
00875197005288
Brand
cobas® 4800 Cdiff Controls and Cofactor Kit
Company
Roche Molecular Systems, Inc.
Model
06768300190
Catalog number
06768300190
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
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197005288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197005288008751970052888751970052880875197005288

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile 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, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.

Regulatory Flags#

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

Other Devices From This Company#

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00875197001068COBAS® AmpliScreen HCV Test, v2.02033025630182014-09-17
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00875197002102COBAS® AmpliScreen HBV Test03599779190035997791902014-09-17
00875197004045cobas® TaqScreen MPX Test, v2.02.0059694841902015-02-20
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00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit09211128190092111281902026-02-24
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00875197006902cobas® TV/MG09040633190090406331902026-02-24
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