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