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) (5)

Premarket Exempt

No Yes

Clear

Solidscreen II Negative Control - 07611969951352 Catalog Number : 806509100

Device Description : Negative Control for Solidscreen II on TANGO instruments; 4 ml

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Alsevers Solution - 07611969951369 Catalog Number : 806510100

Device Description : Suspension medium and stabilizer for red blood cells for TANGO instruments and o Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods

Device Class : 2

Duns Number: 312576506

Premarket Exempt : Yes

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Solidscreen II-Control - 07611969951390 Catalog Number : 806514100

Device Description : Positive Control for Solidscreen II on TANGO instruments; 4 ml

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Anti-Human Globulin Anti-IgG Solidscreen II - 07611969951437 Catalog Number : 806516100

Device Description : Anti-Human Globulin, Anti-IgG, Rabbit; for Solidscreen II with the TANGO instruments; 55ml

Device Class :

Duns Number: 312576506

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Solidscreen II-Control B - 07611969951468 Catalog Number : 806519100

Device Description : Positive Control for Solidscreen II on TANGO instruments; 4ml

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Solidscreen II Strip - 07611969951499 Catalog Number : 806521100

Device Description : Microplate for use in detection of red blood cell antibodies and antigens in ind Microplate for use in detection of red blood cell antibodies and antigens in indirect and direct antiglobulin tests with solid phase antiglobulin technique on TANGO instruments; 10 plates

Device Class : 2

Duns Number: 312576506

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Solidscreen II Anti-D (RH1) Blend - 07611969951512 Catalog Number : 806530100

Device Description : Solidscreen II Human Monoclonal Blend (BS221/H41 11B7); for Solidscreen II with Solidscreen II Human Monoclonal Blend (BS221/H41 11B7); for Solidscreen II with TANGO instruments; 5ml

Device Class :

Duns Number: 312576506

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Seraclone® Anti-S (MNS3) - 07611969951536 Catalog Number : 808052100

Device Description : Blood Grouping Reagent Anti-S (MNS3); Seraclone® Human Monoclonal (MS94); for tu Blood Grouping Reagent Anti-S (MNS3); Seraclone® Human Monoclonal (MS94); for tube test; 2ml

Device Class :

Duns Number: 312576506

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Seraclone® Anti-s (MNS4) - 07611969951550 Catalog Number : 808068100

Device Description : Blood Grouping Reagent Anti-s (MNS4); Seraclone® Human Monoclonal (P3YAN3); for Blood Grouping Reagent Anti-s (MNS4); Seraclone® Human Monoclonal (P3YAN3); for tube test; 2ml

Device Class :

Duns Number: 312576506

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Seraclone® Anti-K (KEL1) - 07611969951574 Catalog Number : 808090100

Device Description : Blood Grouping Reagent Anti-K (KEL1); Seraclone® Human Monoclonal (MS56); for tu Blood Grouping Reagent Anti-K (KEL1); Seraclone® Human Monoclonal (MS56); for tube test; 5ml

Device Class :

Duns Number: 312576506

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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