MONITORX LASERX THEOPHYLLINE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SODIUM AND POTASSIUM BY ION SELECTIVE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

FDA 510(k)

FDA Class 2 ·Microbiology

THERAPEUTIC DRUG MONITORING CONTROL SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

FDA 510(k)

FDA Class 2 ·Hematology

ENZYMATIC CO2 REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETHANOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DURAZYME(R) CPK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KINETIC 610 ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Needle-Pro

FDA registration

ICU Medical, Inc.·1 product·🇺🇸 United States

Advanced Sensor Catheter

FDA registration

ICU MEDICAL, INC·3 products·🇺🇸 United States

Transpac IT

FDA registration

ICU MEDICAL, INC·1 product·🇺🇸 United States

Expressions MR

FDA registration

ICU MEDICAL, INC·1 product·🇺🇸 United States

Bivona® Aire-Cuf® Neonatal and Pediatric Tracheostomy Tubes

FDA registration

ICU Medical, Inc.·1 product·🇺🇸 United States

Bougie

FDA registration

ICU Medical, Inc.·1 product·🇺🇸 United States