FDA.reportPublic FDA data

cobas Buffer Negative Control Kit

Primary DI
00875197006926
Brand
cobas Buffer Negative Control Kit
Company
Roche Diagnostics GmbH
Model
09051953190
Catalog number
09051953190
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NSUInstrumentation for clinical multiplex test systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197006926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197006926008751970069268751970069260875197006926

GMDN Terms#

Term, Definition table
TermDefinition
PCR/NAT negative control IVDA material or solution, known to give a negative result, intended to be used to verify the performance and/or identify contamination, or non-specific amplification in a qualitative and/or quantitative assay performed on a clinical specimen using a nucleic acid technique (NAT) or polymerase chain reaction (PCR).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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