FDA.reportPublic FDA data

Diapharma Factor X Kit

Primary DI
00867885000200
Brand
Diapharma Factor X Kit
Company
DIAPHARMA GROUP INC.
Model
DPGFX
Device description
Chromogenic Factor X
Published
2016-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867885000200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867885000200008678850002008678850002000867885000200

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor X IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor X in a clinical specimen, using a chromogenic method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966721706
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true