STA® - Liatest® Free Protein S 6

GUDID 03607450005165

DIAGNOSTICA STAGO

Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry Protein S IVD, kit, nephelometry/turbidimetry
Primary Device ID03607450005165
NIH Device Record Key1dcf770e-7c57-407a-8ab1-80e91e82fc32
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTA® - Liatest® Free Protein S 6
Version Model Number00516
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
GS103607450005165 [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 Date2016-09-15

Devices Manufactured by DIAGNOSTICA STAGO

03607450009514 - Asserachrom® PF42021-05-11
03607450003482 - STA® - Multi Hep Calibrator2021-05-03
03607450005158 - STA® - Liatest® D-Di2021-05-03
03607450005165 - STA® - Liatest® Free Protein S 62021-05-03
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

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