Asserachrom® tPA

GUDID 03607450009484

DIAGNOSTICA STAGO

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Primary Device ID03607450009484
NIH Device Record Key23b2719b-ee10-431c-8e3c-295cd54ded07
Commercial Distribution StatusIn Commercial Distribution
Brand NameAsserachrom® tPA
Version Model Number00948
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
GS103607450009484 [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

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03607450005967 - STA® - Stachrom® AT III 32021-04-12
03607450005707 - Liatest® Protein S2021-04-08
03607450006056 - STA® - Néoplastine® CI 52021-04-08
03607450006667 - STA® - Néoplastine® CI 102021-04-08
03607450006674 - STA® - Néoplastine® CI Plus 102021-04-08
03607450006834 - STA® - Heparin Control2021-04-08

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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