TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

FDA 510(k)

FDA Class 2 ·Immunology

RABBIT ANTISERUM TO HUMAN IGA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIMETRIC PLUS C3 REAGENT KIT

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Kolplast Cervical Sample Collection Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE SUCTION AND IRRIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ACVTIVE-B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology