Ristocetin (7.5 mg/vial)

GUDID 15391521420081

TCOAG IRELAND LIMITED

Platelet aggregation study IVD, kit, nephelometry/turbidimetry
Primary Device ID15391521420081
NIH Device Record Key8de9b9b3-ee7d-42e7-a30c-e715bbbbd630
Commercial Distribution StatusIn Commercial Distribution
Brand NameRistocetin (7.5 mg/vial)
Version Model Number50705
Company DUNS985039126
Company NameTCOAG IRELAND LIMITED
Device Count10
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105391521420084 [Unit of Use]
GS115391521420081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GHRReagent, Platelet Aggregation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

Devices Manufactured by TCOAG IRELAND LIMITED

15391521421286 - TriniLIZE™ Stabilyte tubes 2019-07-19
15391521420470 - TriniCLOT Lupus Screen2019-07-08
15391521420487 - TriniCLOT Lupus Confirm2019-07-08
15391521420630 - TriniCHECK Level 12019-07-08
15391521420647 - TriniCHECK Level 22019-07-08
15391521420654 - TriniCHECK Level 32019-07-08
15391521421309 - DT Wash2019-07-08
15391521421729 - DT Fluid2019-07-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.