QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

CARIESCAN PRO

FDA 510(k)

FDA Class 2 ·Dental

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

FDA 510(k)

FDA Class 2 ·Hematology

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Erythropoietin (EPO) assay

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT Active-B12 (Holotranscobalamin)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE

MICROMANIPULATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Urease And Glutamic Dehydrogenase, Urea Nitrogen

FDA classification

FDA Class 2 ·Urease And Glutamic Dehydrogenase, Urea Nitrogen

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

FDA classification

FDA Class 2 ·System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection