Lyophilized Platelets

GUDID 05391521420091

TCOAG IRELAND LIMITED

Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry Platelet aggregation study IVD, kit, nephelometry/turbidimetry
Primary Device ID05391521420091
NIH Device Record Key54694612-fcb8-4a52-b7cd-daa107bf9466
Commercial Distribution StatusIn Commercial Distribution
Brand NameLyophilized Platelets
Version Model Number50710
Company DUNS985039126
Company NameTCOAG IRELAND LIMITED
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
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
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
GS105391521420091 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

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