bioMerieux, Inc. - FDA 510(k) Cleared Devices

Cleared May 01, 2024

VIDAS TBI (GFAP, UCH-L1)

K240279 · QAT

Immunology · 90d

Cleared Jun 22, 2009

VIDAS CA 15-3 ASSAY

K080469 · LTK

Immunology · 487d

Cleared Apr 10, 2009

VIDAS CA 125 II ASSAY

K080561 · LTK

Immunology · 407d

Cleared Oct 09, 2008

VIDAS CEA (S) ASSAY

K080194 · DHX

Immunology · 258d

Cleared Sep 26, 2008

VIDAS AFP ASSAY

K080017 · LOJ

Immunology · 267d

Cleared Apr 24, 2001

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

K010550 · LTJ

Immunology · 57d

Cleared Feb 10, 1983

SALMONELLA-SHIGELLA AGAR

K830065 · JSI

Immunology · 30d

Cleared Feb 10, 1983

BILE ESCULIN AZIDE AGAR

K830080 · JSJ

Immunology · 30d

Cleared Feb 10, 1983

BIGGY AGAR

K830082 · JSI

Immunology · 30d

Cleared Feb 09, 1983

MUELLER HINTON W/50% SHEEP BLOOD

K830059 · JTC

Immunology · 29d

Cleared Feb 09, 1983

MUELLER HINTON

K830060 · JTZ

Immunology · 29d

Cleared Feb 09, 1983

THAYER-MARTIN, MODIFIED

K830061 · JTY

Immunology · 29d