Asserachrom® Free Protein S

GUDID 03607450009460

DIAGNOSTICA STAGO

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Primary Device ID03607450009460
NIH Device Record Key5199663b-2f49-4dee-bb82-d3e77271f4f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAsserachrom® Free Protein S
Version Model Number00946
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103607450009460 [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 Date2021-04-08
Device Publish Date2016-09-15

Devices Manufactured by DIAGNOSTICA STAGO

03607450006711 - STA® - Stachrom® Protein C2021-04-15
03607450006780 - STA® - System Control N + P2021-04-15
03607450007466 - STA® - Staclot® Protein S2021-04-15
03607450007473 - STA® - Staclot® Protein C 12021-04-15
03607450008579 - F.S. Test2021-04-15
03607450008876 - F.S. Test Unit2021-04-15
03607450009064 - Stachrom® Heparin2021-04-15
03607450009439 - Asserachrom® IX:Ag2021-04-15

Trademark Results [Asserachrom]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASSERACHROM
ASSERACHROM
73407804 1302313 Live/Registered
S.E.M.S. Societe d'Etudes et d'Exploitation de Marques et Brevets
1982-12-30

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