AMERICAN NATIONAL RED CROSS

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Filters

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

Media, Potentiating For In Vitro Diagnostic Use (KSG) (2) Diluent, Blood Cell (GIF) (1)

Premarket Exempt

No Yes

Clear

PEG - 00858400005107 Catalog Number :

Device Description : PEG is an additive solution intended for use as a potentiator in antibody detect PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from Polyethylene glycol (PEG) in a low ionic strength solution.

Device Class : 2

Duns Number: 003255213

Premarket Exempt : Yes

Product Code : KSG

Prescription Use : No

Device Count : 1

Red Cell Storage Solution - 00858400005114 Catalog Number :

Device Description : Red Cell Storage Solution is intended for use in the dilution and/or preservatio Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purposes of in vitro immunohematology testing.

Device Class : 1

Duns Number: 003255213

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : Yes

Device Count : 1

LISS - 00858400005121 Catalog Number :

Device Description : LISS is an additive solution intended for use as a potentiator in antibody detec LISS is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from glycine and albumin.

Device Class : 2

Duns Number: 003255213

Premarket Exempt : Yes

Product Code : KSG

Prescription Use : No

Device Count : 1

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