Diapharma Factor X Kit

GUDID 00867885000200

Chromogenic Factor X

DIAPHARMA GROUP INC.

Coagulation factor X IVD, kit, chromogenic
Primary Device ID00867885000200
NIH Device Record Key6678d9c7-de74-4395-9e45-8b961f4524cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiapharma Factor X Kit
Version Model NumberDPGFX
Company DUNS966721706
Company NameDIAPHARMA GROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100867885000200 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-14

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