BIO-RAD

BIO-RAD

Address:7 RUE DE MADRID,SCHILTIGHEIM Bas-Rhin,FR

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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

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (JSO) (3) Hepatitis A Test (Antibody And Igm Antibody) (LOL) (2) Reagent, Borrelia Serological Reagent (LSR) (2) Test, Hiv Detection (MZF) (2) Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (1)

Premarket Exempt

No

Clear

MONOLISA - 00847865012362 Catalog Number : 72496

Device Description : MONOLISA Anti-HAV EIA

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : LOL

Prescription Use : No

Device Count : 1

MONOLISA - 00847865012379 Catalog Number : 72495

Device Description : MONOLISA Anti-HAV IgM EIA

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : LOL

Prescription Use : No

Device Count : 1

Select - 03610520002933 Catalog Number : 63747

Device Description : MRSASelect

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : JSO

Prescription Use : No

Device Count : 1

Select - 03610520002971 Catalog Number : 63751

Device Description : VRESelect

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : JSO

Prescription Use : No

Device Count : 1

PLATELIA - 03610520007853 Catalog Number : 26211

Device Description : PLATELIA Toxo IgM

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

PLATELIA - 03610520007860 Catalog Number : 25296

Device Description : PLATELIA Lyme IgM

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

PLATELIA - 03610520007877 Catalog Number : 25297

Device Description : PLATELIA Lyme IgG

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Geenius - 03610520013847 Catalog Number : 72461

Device Description : Geenius HIV 1/2 Supplemental assay

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

Geenius - 03610520013854 Catalog Number :

Device Description : Geenius HIV 1/2 Controls

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

Select - 03610521536208 Catalog Number :

Device Description : MRSASelectTM II - 20 tests

Device Class : 2

Duns Number: 269902602

Premarket Exempt : No

Product Code : JSO

Prescription Use : No

Device Count : 1

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