FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FACTPLUS ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

Test, Immunoassay, Biosensor, Hcg

FDA classification

FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

Visual, Pregnancy Hcg, Prescription Use

FDA classification

FDA Class 2 ·Visual, Pregnancy Hcg, Prescription Use

E3-80 PORTABLE ECG RECORDER & ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

Kit, Test, Pregnancy, Hcg, Over The Counter

FDA classification

FDA Class 2 ·Kit, Test, Pregnancy, Hcg, Over The Counter

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

MONOHAEM (FECAL OCCULT BLOOD TEST)

FDA 510(k)

FDA Class 2 ·Hematology