STA® - Staclot® Protein C 3

GUDID 03607450007374

DIAGNOSTICA STAGO

Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting Protein C IVD, kit, clotting
Primary Device ID03607450007374
NIH Device Record Keycab53647-ec06-4940-b688-afbfc190b75b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTA® - Staclot® Protein C 3
Version Model Number00737
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
GS103607450007374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGPTEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

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 Date2017-12-06

Devices Manufactured by DIAGNOSTICA STAGO

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03607450005158 - STA® - Liatest® D-Di2021-05-03
03607450005165 - STA® - Liatest® Free Protein S 62021-05-03
03607450005400 - FDP Plasma2021-05-03
03607450005974 - STA® - C.K. Prest® 52021-05-03
03607450006001 - Staclot® LA2021-05-03
03607450006063 - STA® - Néoplastine® CI Plus 52021-05-03

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