STA® - HBPM/LMWH Control

GUDID 03607450006827

DIAGNOSTICA STAGO

Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control Heparin anti-Xa IVD, control
Primary Device ID03607450006827
NIH Device Record Keyb5baadd6-f8cf-4d5a-bfa3-5d945ad5545c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTA® - HBPM/LMWH Control
Version Model Number00682
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
GS103607450006827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KFFASSAY, HEPARIN

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

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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
03607450006155 - Asserachrom® HPIA2021-05-03

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