REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON

FDA 510(k)

FDA Class 2 ·Immunology

LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)

FDA 510(k)

FDA Class 2 ·Immunology

N ANTISERUM TO C1 INHIBITOR

FDA 510(k)

FDA Class 2 ·Immunology

MIRACLE-EAR DIGITAL BTE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

DIMENSION TRNF FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

MICROSCAN SYNERGIES PLUS

FDA 510(k)

FDA Class 2 ·Microbiology

PROC APC ASSAY, PROC CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

ANTI-DNASE B REAGENT SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology

N/T PROTEIN CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DRIED GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SHARP II FULL CONTOUR

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

N LATEX IGA

FDA 510(k)

FDA Class 2 ·Immunology

TRANSEAR BONE CONDUCTION HEARING AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry