FRANCISELLA TULARENSIS ANTISERUM

Primary DI
00695684017026
Brand
FRANCISELLA TULARENSIS ANTISERUM
Company
GERMAINE LABORATORIES, INC
Model
1702
Device description
Francisella Tularensis Antiserum is intended for use as a postive control for Francisella Tularensis Antigens.
Published
2016-04-21
Public version status
Update
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
GSKAntiserum, Francisella Tularensis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSKAntiserum, Francisella TularensisMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684017026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684017026006956840170266956840170260695684017026

GMDN Terms#

Term, Definition table
TermDefinition
Francisella tularensis total antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Francisella tularensis in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Francisella tularensis, the bacteria associated with Tularaemia.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176458115
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00695684885304AIMSTRIP PREGNANCY885302016-04-11
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00695684891015AccuHome Pregnancy Test891012016-04-11
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382902409397BD Francisella Tularensis AntiserumBECTON, DICKINSON AND COMPANYGSK2016-05-19