STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK

FDA 510(k)

FDA Class 2 ·Immunology

ENZYGNOST ANTI-CMV IGG TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPUS B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPUS PSA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BATROXOBIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

FDA 510(k)

FDA Class 2 ·Hematology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

BERICHROM(R) ANTITHROMBIN III

FDA 510(k)

FDA Class 2 ·Hematology

TACTIL EAR

FDA 510(k)

FDA Unclassified ·Unknown

LASER STANDARD SERUM

FDA 510(k)

FDA Class 1 ·Immunology

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology