Serodia TP-PA Kits

FDA UDI

FUJIREBIO DIAGNOSTICS, INC.·00869164000055·100 test kit

Serodia TP-PA

FDA UDI

FUJIREBIO DIAGNOSTICS, INC.·00850212007027·220 test kit

Vitamin D Control

FDA UDI

FUJIREBIO DIAGNOSTICS, INC.·00850212007089·

Emit Cyclosporine Sample

FDA UDI

FUJIREBIO DIAGNOSTICS, INC.·00869164000079·

ROMA

FDA UDI

Fujirebio Diagnostics, Inc.·00869164000024·ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

Fertility Control

FDA UDI

FUJIREBIO DIAGNOSTICS, INC.·00850212007072·

ARCHITECT ROMA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARCHITECT CA 15-3 ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G Progesterone-N Calibrators

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lumipulse G LH Calibrators

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lumipulse G E2-III Calibrators

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS CA 19-9

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT TACROLIMUS: MODEL 1L77

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

FDA 510(k)

FDA Class 2 ·Immunology

LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

FDA 510(k)

FDA Class 2 ·Immunology

FUJIREBIO DIAGNOSTICS CA 19-9 RIA

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G TP-N Immunoreaction Cartridge Set

FDA 510(k)

FDA Class 2 ·Microbiology

FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Lumipulse G CA15-3

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G CA19-9-N

FDA 510(k)

FDA Class 2 ·Immunology