8,093 results · 137ms · Sources: EU EUDAMED, US FDA

Flowflex COVID-19 Antigen Home Test

FDA 510(k)
FDA Class 2 ·Microbiology

QUIK-CHECK OVULATION PREDICTOR

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE

FDA 510(k)
FDA Class 1 ·Microbiology

FSH MENOPAUSE PREDICTOR TEST

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Flowflex Plus COVID-19 + Flu A/B Home Test

FDA 510(k)
FDA Class 2 ·Microbiology

ACON MIDSTREAM PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

On Call Express Pro Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACON TRI-FECT DRUG SCREEN TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ON CALL MULTI-DRUG HOME TEST CUP

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACON U120 URINE ANALYZER, MODEL U111-101

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)

FDA 510(k)
FDA Class 2 ·Immunology