TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYSMEX MODEL XT-4000I

FDA 510(k)

FDA Class 2 ·Hematology

URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYSMEX NE-8000

FDA 510(k)

FDA Class 2 ·Hematology

ELECTROSURGICAL ELECTRODE

FDA 510(k)

FDA Class 2 ·Dental

IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

QUIKSTRIP ONE STEP METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MONOCLONAL ANTIBODY ANTI-CD5

FDA 510(k)

FDA Class 2 ·Hematology

RDW AND MPV INDICES ON HEMAT 12

FDA 510(k)

FDA Class 2 ·Hematology

UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

DRI ECSTASY ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

XW-100 Automated Hematology Analyzer, XW QC CHECK

FDA 510(k)

FDA Class 2 ·Hematology

EMIT HVA AMPHETAMINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology