STA® - Néoplastine® CI Plus 5

GUDID 03607450006063

DIAGNOSTICA STAGO

Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting
Primary Device ID03607450006063
NIH Device Record Keyb6d47916-0ef5-49b3-8886-a969c5cfc84d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTA® - Néoplastine® CI Plus 5
Version Model Number00606
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
GS103607450006063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GJSTEST, TIME, PROTHROMBIN

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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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
03607450006063 - STA® - Néoplastine® CI Plus 52021-05-03
03607450006155 - Asserachrom® HPIA2021-05-03

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