ALLURA 3D-CA, RELEASE 1

FDA 510(k)

FDA Class 2 ·Radiology

PULSERA

FDA 510(k)

FDA Class 2 ·Radiology

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION DRUG CALIBRATOR, MODEL DC22B

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION ALDL CALIBRATOR, MODEL DC131

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica CH Amylase_2 (AMY_2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Anti-Jcv Antibody Detection Assay

FDA classification

FDA Class 2 ·Anti-Jcv Antibody Detection Assay

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA classification

FDA Class 2 ·Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Alkaline Phosphatase

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535