STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

FDA 510(k)

FDA Class 2 ·Hematology

Atellica® CH Diazo Total Bilirubin (D_TBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT

FDA 510(k)

FDA Class 2 ·Immunology

Alkaline Phosphatase

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Blood Pressure Cuff

FDA classification

FDA Class 2 ·Blood Pressure Cuff

Implant, Endosseous, Orthodontic

FDA classification

FDA Class 2 ·Implant, Endosseous, Orthodontic

Cabinet, Emission Computed Tomography System

FDA classification

FDA Class 2 ·Cabinet, Emission Computed Tomography System

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

FDA classification

FDA Class 2 ·Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Ultraviolet Radiation Disinfection Chamber Device

FDA classification

FDA Class 2 ·Ultraviolet Radiation Disinfection Chamber Device

Absorbable Gel For Intraoperative Use In Spine Surgery

FDA classification

FDA Class 2 ·Absorbable Gel For Intraoperative Use In Spine Surgery

N95 Respirator With Antimicrobial/Antiviral Agent

FDA classification

FDA Class 2 ·N95 Respirator With Antimicrobial/Antiviral Agent

Surgical Mask With Antimicrobial/Antiviral Agent

FDA classification

FDA Class 2 ·Surgical Mask With Antimicrobial/Antiviral Agent

Custom Anesthesia Tray

FDA classification

FDA Class 2 ·Custom Anesthesia Tray

Dialysis Administration Kit

FDA classification

FDA Class 2 ·Dialysis Administration Kit