FDA.reportPublic FDA data

Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit

Primary DI
00854624006005
Brand
Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit
Company
IVD RESEARCH, INC.
Model
C/G-DFA
Catalog number
C/G-DFA
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854624006005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854624006005008546240060058546240060050854624006005

GMDN Terms#

Term, Definition table
TermDefinition
Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from species of the parasitic protozoan Cryptosporidium in a clinical specimen, using a direct fluorescent test (DFT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965482789
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true