AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

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

PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Kit, Typing, Hla-Dqb

FDA classification

FDA Class 2 ·Kit, Typing, Hla-Dqb

Haptoglobin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Haptoglobin, Fitc, Antigen, Antiserum, Control

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA classification

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