BIOMERIEUX SA

Address:PARC TECHNOLOGIQUE DELTA SUD,VERNIOLLE Ariege,FR

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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

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (2) Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (KLI) (1) RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE (CGJ) (1) RADIOIMMUNOASSAY, LUTEINIZING HORMONE (CEP) (1) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (1) Radioimmunoassay, Total Triiodothyronine (CDP) (1) Reagent, Borrelia Serological Reagent (LSR) (1) Antibody Igm,If, Cytomegalovirus Virus (LKQ) (1) Visual, Pregnancy Hcg, Prescription Use (JHI) (1)

Premarket Exempt

No Yes

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VIDAS® CMV IgM - 03573026156848 Catalog Number :

Device Description : VIDAS ® CMV IgM (CMVM) assay is an automated qualitative IA intended for use on VIDAS ® CMV IgM (CMVM) assay is an automated qualitative IA intended for use on VIDAS family instrument for detection of anti - CMV IgM antibodies in human serum.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LKQ

Prescription Use : Yes

Device Count : 1

VIDAS® TOXO IgG II - 03573026156855 Catalog Number :

Device Description : TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family i TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LGD

Prescription Use : Yes

Device Count : 1

VIDAS® TOXO Compétition - 03573026156862 Catalog Number :

Device Description : VIDAS ® TOXO Competition assay is an automated qualitative IA intended for use o VIDAS ® TOXO Competition assay is an automated qualitative IA intended for use on VIDAS family instrument for the screening of total anti - Toxoplasma in human serum or plasma.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LGD

Prescription Use : Yes

Device Count : 1

VIDAS® Lyme IgG and IgM - 03573026156879 Catalog Number :

Device Description : The VIDAS ® Lyme IgG and IgM assay for use on VIDAS family instruments for the The VIDAS ® Lyme IgG and IgM assay for use on VIDAS family instruments for the presumptive detection of total antibodies (IgG/IgM) to Borrelia burgdorferi

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

VIDAS® TSH - 03573026156886 Catalog Number :

Device Description : VIDAS TSH assay is intended for the determination of human TSH concentration in VIDAS TSH assay is intended for the determination of human TSH concentration in human serum or plasma as an aid in the diagnosis of thyroid or pituitary disorders.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

VIDAS® T3 - 03573026156909 Catalog Number :

Device Description : The VIDAS ® T3 (T3) assay is intended for use on the VIDAS instruments for the q The VIDAS ® T3 (T3) assay is intended for use on the VIDAS instruments for the quantitative determination of triiodothyronine (T3) concentration in serum or plasma (heparin).

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : CDP

Prescription Use : Yes

Device Count : 1

VIDAS® T4 - 03573026156916 Catalog Number :

Device Description : The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the d The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the determinat ion of human thyroxine (T4) concentration in serum or plasma (heparin).

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : KLI

Prescription Use : Yes

Device Count : 1

VIDAS® HCG - 03573026156923 Catalog Number :

Device Description : VIDAS ® HCG (HCG) assay is a quantitative immunoassay intended for use on VIDAS VIDAS ® HCG (HCG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of hCG concentration in human serum or plasma.

Device Class : 2

Duns Number: 276816717

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

VIDAS® LH - 03573026156930 Catalog Number :

Device Description : VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS fam VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of LH concentration in human serum or plasma .

Device Class : 1

Duns Number: 276816717

Premarket Exempt : No

Product Code : CEP

Prescription Use : Yes

Device Count : 1

VIDAS® FSH - 03573026156947 Catalog Number :

Device Description : VIDAS® FSH (FSH) assay is a quantitative immunoassay intended for use on VIDAS f VIDAS® FSH (FSH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of FSH concentration in human serum or plasma

Device Class : 1

Duns Number: 276816717

Premarket Exempt : No

Product Code : CGJ

Prescription Use : Yes

Device Count : 1

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