Bio-RAD Laboratories, Inc.

Address:2500 Atlas Rd,Richmond,CA,94804,US

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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

Antisera, fluorescent, herpesvirus hominis 1,2 (GQL) (5) PNEUMOCYSTIS CARINII (LYF) (2) ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL (DBM) (1) REAGENT, BORRELIA SEROLOGICAL REAGENT (LSR) (1) REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT (LHL) (1)

Premarket Exempt

Clear

Kallestad - 00847865001205 Catalog Number : 30403

Device Description : Kallestad Mounting Media

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : DBM

Prescription Use : No

Device Count : 1

Pathfinder - 00847865001212 Catalog Number : 30490

Device Description : HSV Type 1 Monoclonal Antibody

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Bio-Rad Laboratories, Inc. - 00847865001274 Catalog Number : 32507

Device Description : Anti-Borrelia (Lyme) Microplate EIA

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Pathfinder - 00847865001403 Catalog Number : 30693

Device Description : Pathfinder Mounting Media

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Pathfinder - 00847865001465 Catalog Number : 25215

Device Description : Herpes Simplex Virus Types 1 and 2 Direct Antigen Detection System

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Pathfinder - 00847865001472 Catalog Number : 30491

Device Description : HSV Type 2 Monoclonal Antibody

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Pathfinder - 00847865001489 Catalog Number : 30494

Device Description : HSV Type 1 and 2, 2 Well Slides

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Kallestad - 00847865001496 Catalog Number : 32514

Device Description : MONOFLUO Legionella pneumophila IFA Test Kit

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : LHL

Prescription Use : No

Device Count : 1

MONOFLUO - 00847865001502 Catalog Number : 32524

Device Description : MONOFLUO Fluorescence Microscopy Slides

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : LYF

Prescription Use : No

Device Count : 1

MONOFLUO - 00847865001519 Catalog Number : 32515

Device Description : MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test

Device Class : 2

Duns Number: 844766394

Premarket Exempt : No

Product Code : LYF

Prescription Use : No

Device Count : 1

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