Asserachrom® D-Di

GUDID 03607450009477

DIAGNOSTICA STAGO

D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA) D-dimer IVD, kit, enzyme immunoassay (EIA)
Primary Device ID03607450009477
NIH Device Record Key39140ace-225f-4e9b-8de2-d3862f13b489
Commercial Distribution StatusIn Commercial Distribution
Brand NameAsserachrom® D-Di
Version Model Number00947
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
GS103607450009477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

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

03607450003482 - STA® - Multi Hep Calibrator2021-05-03
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

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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