194 results · 112ms · Sources: EU EUDAMED, US FDA

ARK™ Gabapentin Calibrator

FDA UDI
ARK DIAGNOSTICS INC·00858724003100·The ARK™ Gabapentin Calibrator is intended for...

ARK™ HS Benzodiazepine II Negative Calibrator

FDA UDI
ARK DIAGNOSTICS INC·00812101030516·ARK™ HS Benzodiazepine II Negative Calibrator i...

ARK™ Ethyl Glucuronide Assay (115mL)

FDA UDI
ARK DIAGNOSTICS INC·00858724003476·The ARK™ Ethyl Glucuronide Assay is intended f...

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Fentanyl Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Methotrexate Assay

FDA 510(k)
FDA Unclassified ·Unknown

ARK Levetiracetam II Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Tramadol Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Fentanyl II Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Hydrocodone Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK EDDP Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN

FDA 510(k)
FDA Unclassified ·Unknown

ARK Methotrexate II Assay

FDA 510(k)
FDA Unclassified ·Unknown

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Voriconazole II Assay Test System

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Lacosamide Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology