CALTAG MEDSYSTEMS LIMITED

Address:Whiteleaf Business Centre,Buckingham Buckinghamshire,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tubes, Vacuum Sample, With Anticoagulant (GIM) (1)

Premarket Exempt

Clear

TransFix/EDTA Vacuum Blood Collection Tubes - 05060531711627 Catalog Number :

Device Description : TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection a TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells by flow cytometry. Recovery of lymphocyte subset markers of the HIV panel can be accomplished over a 14-day period following collection. TVTs are in-vitro diagnostic medical devices.

Device Class :

Duns Number: 221434843

Premarket Exempt : No

Product Code : GIM

Prescription Use : Yes

Device Count : 1

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