STA® - C.K. Prest® 5

GUDID 03607450005974

DIAGNOSTICA STAGO

Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting
Primary Device ID03607450005974
NIH Device Record Keyf6506396-9774-44f5-aa4b-9e0d7bb7a939
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTA® - C.K. Prest® 5
Version Model Number00597
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
GS103607450005974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGWTEST, TIME, PARTIAL THROMBOPLASTIN

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

Devices Manufactured by DIAGNOSTICA STAGO

03607450003482 - STA® - Multi Hep Calibrator2021-05-03
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
03607450005974 - STA® - C.K. Prest® 52021-05-03
03607450006001 - Staclot® LA2021-05-03
03607450006063 - STA® - Néoplastine® CI Plus 52021-05-03
03607450006155 - Asserachrom® HPIA2021-05-03

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.