FDP Plasma

GUDID 03607450005400

DIAGNOSTICA STAGO

Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination Fibrinogen degradation product (FDP) IVD, kit, agglutination
Primary Device ID03607450005400
NIH Device Record Key9a7cfab7-6d31-400f-9727-812fd9b2cd0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFDP Plasma
Version Model Number00540
Company DUNS262277122
Company NameDIAGNOSTICA STAGO
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103607450005400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-03
Device Publish Date2016-09-15

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