FDA.reportPublic FDA data

cobas&#x00AE WNV Control Kit

Primary DI
00875197005011
Brand
cobas&#x00AE WNV Control Kit
Company
Roche Diagnostics GmbH
Model
07001118190
Catalog number
07001118190
Published
2017-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197005011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197005011008751970050118751970050110875197005011

GMDN Terms#

Term, Definition table
TermDefinition
West Nile virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from West Nile virus in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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