SEEKER System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NeoLSD MSMS Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NeoLSD MSMS kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DX-D FULL LEG FULL SPINE

FDA 510(k)

FDA Class 2 ·Radiology

S-TEST CREATININE (CRE)

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

S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW TROPONIN I TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTANT-VIEW MORPHINE URINE CASSETTE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry