ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARBLUE EASY DIGITAL PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNTRON BIORESEARCH U-TEST PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIA Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSOM CARD PREGNANCY TEST, MODEL 103

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HOSPITAL LAB IN-HOME EARLY PREG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Distinct® Early Detection Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARPLAN EASY II HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

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

Test, Immunoassay, Biosensor, Hcg

FDA classification

FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Visual, Pregnancy Hcg, Prescription Use

FDA classification

FDA Class 2 ·Visual, Pregnancy Hcg, Prescription Use

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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