LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DGTX FLEX REAGENT CARTRIDGE, MODEL DF36

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FERR FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

ACA THYRONINE UPTAKE (TU E) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TPSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N LP(A) STANDARD SY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYSMEX AUTOMATED COAGULATION ANALYZER CA-500

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRONEX REGULAR CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT C-REACTIVE PROTEIN (CRP) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N APOLIPOPROTEIN STANDARD SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

FDA 510(k)

FDA Class 2 ·Immunology

CONTROL PLASMA N AND CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology