BIO-FLASH System Rinse

Device

EU IVDR · Eu Ivd Class A ·Biokit S.A.·On the market·30 countries

BIO-FLASH Triggers

Device

EU IVDR · Eu Ivd Class A ·Biokit S.A.·On the market·30 countries

BIO-FLASH Cuvettes

Device

EU IVDR · Eu Ivd Class A ·Biokit S.A.·On the market·30 countries

BIO-FLASH

Device

EU IVDR · Eu Ivd Class A ·Biokit S.A.·On the market·30 countries

Lp(a)

Device

EU IVDR · Eu Ivd Class B ·Biokit S.A.·On the market·5 countries

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Herpes-1 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

ADVIA Centaur EBV-VCA IgM

FDA 510(k)

FDA Class 1 ·Microbiology

QUANTIA IGE

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LP(A) CALIBRATORS, AND LP(A) CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTIA A1-AT

FDA 510(k)

FDA Class 2 ·Immunology

Quantia IgE

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

FDA 510(k)

FDA Class 2 ·Microbiology

ADVIA Centaur EBV-EBNA IgG

FDA 510(k)

FDA Class 1 ·Microbiology

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Herpes-2 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

QUANTIA BETA-2 MICROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology