Bio-Rad Medical Diagnostics GmbH

Address:INDUSTRIESTR. 1,DREIEICH Hesse,DE

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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

System, Test, Automated Blood Grouping And Antibody (KSZ) (6) Manual Blood Grouping And Antibody Test Systems (PBC) (2) Diluent, Blood Cell (GIF) (1) Media, Potentiating For In Vitro Diagnostic Use (KSG) (1)

Premarket Exempt

No Yes

Clear

IH-Com - 03610520569870 Catalog Number : 009100

Device Description : IH-Com Kit Fullversion US; Software Version: 04.0.27.

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

IH-Card ABO Neutral - 03610522055685 Catalog Number : 12008722

Device Description : The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antib The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 1

IH-Com V5.2 - 03610522123919 Catalog Number : 12010236

Device Description : IH-Com V5.2, Software Version 5.2

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Wash Solution A Concentrate - 03610522165049 Catalog Number :

Device Description : Wash Solution for use with the IH-500

Device Class : 1

Duns Number: 312576506

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : Yes

Device Count : 1

IH-LISS Rack - 07611969069934 Catalog Number : 813510100

Device Description : LISS in racks for IH-1000 Analyzer

Device Class : 2

Duns Number: 312576506

Premarket Exempt : Yes

Product Code : KSG

Prescription Use : Yes

Device Count : 1

IH-Reader 24 - 07611969205486 Catalog Number : 001200

Device Description : A combination centrifuge and reader for IH gel cards

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

IH-1000 - 07611969205493 Catalog Number : 001100

Device Description : Fully automated system for immunohematology diagnostics

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

IH-Centrifuge L - 07611969226320 Catalog Number :

Device Description : IH-Centrifuge L for centrifugation of IH-System gel cards and/or test tubes.

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : PBC

Prescription Use : Yes

Device Count : 1

IH-Incubator L - 07611969226344 Catalog Number :

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : PBC

Prescription Use : Yes

Device Count : 1

IH-500 - 07611969233786 Catalog Number : 001510

Device Description : IH-500 is an automated instrument intended for the in vitro serological analysis IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

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