i-STAT BNP Controls

FDA registration

ABBOTT POINT OF CARE INC.·1 product·🇺🇸 United States

Cardiac marker complete

FDA registration

CLINIQA CORPORATION·1 product·🇺🇸 United States

i-STAT BNP Controls

FDA registration

ABBOTT POINT OF CARE CANADA LIMITED·1 product·🇨🇦 Canada

RAMP Cardiac Controls

FDA registration

Response Biomedical Corp.·1 product·🇨🇦 Canada

Cardiac Linearity Verifiers

FDA registration

RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Reusable Adult/Pediatric Ear Clip SpO2 Sensor (1.5m) (M1194A)

FDA registration

Philips Medizin Systeme Boeblingen GmbH·2 products·🇩🇪 Germany

Carolina Liquid Chemistries Corp.

FDA registration

Carolina Liquid Chemistries Corp.·1 product·🇺🇸 United States

Reusable Adult/Pediatric Ear Clip SpO2 Sensor (1.5m) (M1194A)

FDA registration

Philips Medical Systems Ltda·2 products·🇧🇷 Brazil

BEHRING COAGULATION SYSTEM (BCS)

FDA 510(k)

FDA Class 2 ·Hematology

DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Multi-Analyte Controls, All Kinds (Assayed)

FDA classification

FDA Class 1 ·Multi-Analyte Controls, All Kinds (Assayed)

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

FDA classification

FDA Class 2 ·Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

System, Multipurpose For In Vitro Coagulation Studies

FDA classification

FDA Class 2 ·System, Multipurpose For In Vitro Coagulation Studies