URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STREPTOCOCCUS MIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

FIBRINOGEN CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN

FDA 510(k)

FDA Class 2 ·Microbiology

N LATEX CYSTATIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DGTX FLEX REAGENT CARTRIDGE, MODEL DF36

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DRIED GRAM-NEGATIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

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

N LP(A) STANDARD SY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/

FDA 510(k)

FDA Class 2 ·Hematology

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

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology