50NG/ML COCAINE METABOLITE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA TOBRAMYCIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QMS LIDOCAINE CALIBRATORS, MODEL 0374678

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT 2000 VANCOMYCIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SHARE INT'L TDM

FDA 510(k)

FDA Class 2 ·Neurology

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT COLUMN DIGOXIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN ONLINE BENZ 200 CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THEOPHYLLINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CYCLOSPORINE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Morgan™ HLA SSP ABCDRDQ Typing Kit, 1 test/tray(20tests)

Device

EU IVDD · Eu Ivd Annex 2 List B ·TBG Biotechnology Corp.·On the market·3 countries

Morgan™ HLA SSP ABDR Typing Kit, 1 test/tray(20tests)

Device

EU IVDD · Eu Ivd Annex 2 List B ·TBG Biotechnology Corp.·On the market·3 countries

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER

Barbiturate Enzyme Immunoassay

FDA registration

LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States

Oral Fluid Amphetamine Enzyme Immunoassay

FDA registration

LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States