Chemtrue Multi-Panel DOA DIP Card Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIFESIGN DOA 4 (THC/OPI/COC/MET)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

FREEMIE BREAST COLLECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FREEMIE (R)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Freemie Independence, Freemie Liberty

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vial Adapter Ø20 mm , Vial Adapter Ø13 mm

FDA 510(k)

FDA Class 2 ·General Hospital

Vial Adapter Ø20 mm

FDA 510(k)

FDA Class 2 ·General Hospital