Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T

Cassini

FDA registration

HITTECH MULTIN BV·1 product·🇳🇱 Netherlands

PCP Urine HEIA 500 mL Kit

FDA registration

Alere San Diego Inc.·2 products·🇺🇸 United States

Emit Cal/Controls Levels 0-5

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·2 products·🇺🇸 United States

Emit tox Acetaminophen Assay

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·2 products·🇺🇸 United States

Barbiturates Urine HEIA Kit 25

FDA registration

Alere San Diego Inc.·2 products·🇺🇸 United States

ABUS ONLINE LSD CAL/CTRL PK

FDA registration

ROCHE DIAGNOSTICS GMBH·2 products·🇩🇪 Germany

445824 Cannabinoid 20 ng Reagent (THC2 1 x 150)

FDA registration

BECKMAN COULTER, INC.·2 products·🇺🇸 United States

Dimension LIDO Flex

FDA registration

Siemens Healthcare Diagnostics Inc.·2 products·🇺🇸 United States

Emit 2000 Valproic Acid Cals

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·2 products·🇺🇸 United States

CFAS DAT QUALITATIVE PLUS CLINICAL

FDA registration

ROCHE DIAGNOSTICS GMBH·2 products·🇩🇪 Germany

Dimension LIDO Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·2 products·🇺🇸 United States

ARCHITECT iCarbamazepine Calibrators (LN 1P36-01)

FDA registration

ABBOTT LABORATORIES·2 products·🇺🇸 United States

Multi-Analyte Set B Urine Drug of Abuse Controls

FDA registration

LIN-ZHI INTERNATIONAL, INC.·2 products·🇺🇸 United States

ARCHITECT iCarbamazepine Calibrators (LN 1P36-01)

FDA registration

ABBOTT GmbH·2 products·🇩🇪 Germany

Methamphetamine Urine HEIA Kit 100

FDA registration

Alere San Diego Inc.·2 products·🇺🇸 United States

Benzodiazepines Urine HEIA 25 mL Kit

FDA registration

Alere San Diego Inc.·2 products·🇺🇸 United States

ACET2 Calibrator

FDA registration

ROCHE DIAGNOSTICS GMBH·2 products·🇩🇪 Germany

Emit 2000 Valproic Acid Cals

FDA registration

Siemens Healthcare Diagnostics Inc.·2 products·🇺🇸 United States