HEMO BIOSCIENCE INC

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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

Kit, Quality Control For Blood Banking Reagents (KSF) (4) Media, Potentiating For In Vitro Diagnostic Use (KSG) (1)

Premarket Exempt

No Yes

Clear

Hemo-QC - 00858352006009 Catalog Number : H9200

Device Description : Hemo-QC simulates blood samples and is intended for the daily quality control of Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.

Device Class : 2

Duns Number: 143647035

Premarket Exempt : No

Product Code : KSF

Prescription Use : Yes

Device Count : 1

C3 Control Cells - 00858352006016 Catalog Number : H9000

Device Description : C3 Control Cells are used to confirm the reactivity of anti-C3 in Anti-human globulin.

Device Class : 2

Duns Number: 143647035

Premarket Exempt : No

Product Code : KSF

Prescription Use : Yes

Device Count : 1

ELUclear - 00858352006023 Catalog Number : H360

Device Description : ELUclear elution kit is used to elute antibodies from intact red blood cells.

Device Class : 2

Duns Number: 143647035

Premarket Exempt : Yes

Product Code : KSG

Prescription Use : No

Device Count : 1

MQC - 00858352006122 Catalog Number :

Device Description : MQC is intended for the quality control of routine blood bank reagents when test MQC is intended for the quality control of routine blood bank reagents when tested by tube technique.

Device Class : 2

Duns Number: 143647035

Premarket Exempt : No

Product Code : KSF

Prescription Use : Yes

Device Count : 1

MQC-CAT - 00858352006139 Catalog Number :

Device Description : MQC-CAT is intended for the quality control of routine blood bank reagents when MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques.

Device Class : 2

Duns Number: 143647035

Premarket Exempt : No

Product Code : KSF

Prescription Use : Yes

Device Count : 1

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