VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TGL FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IODOSORB POWDER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

IODOSORB GEL

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

DIMENSION EXL WITH LM SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

Atellica CH Magnesium (Mg)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

INFLUENZA HI PRESERUM

FDA 510(k)

FDA Class 1 ·Microbiology

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

FDA 510(k)

FDA Class 1 ·Microbiology

MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

FDA 510(k)

FDA Class 1 ·Microbiology

D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

FDA 510(k)

FDA Class 1 ·Microbiology

GOAT ANTIINFLUENZA ANTISERA AUSSR

FDA 510(k)

FDA Class 1 ·Microbiology

INFLUENZA B ANITGEN TEST

FDA 510(k)

FDA Class 1 ·Microbiology

VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY

FDA 510(k)

FDA Class 1 ·Microbiology