Dimension Vista MMB Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISA ENZ 2 CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXL ANEM CAL, MODEL RC640

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica CH Amylase_2 (AMY_2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSIONS HB1C KIT, MODEL DF105A

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

FDA 510(k)

FDA Class 2 ·Immunology