OPD-SCAN, MODELS ARK-10000 AND ARK-9000

FDA 510(k)

FDA Class 1 ·Ophthalmic

anti-p40 (BC28) Mouse Monoclonal Primary Antibody

FDA UDI

Ventana Medical Systems, Inc.·04015630976423·

LapBox Tissue Containment Removal System

FDA UDI

ARK SURGICAL LTD·07290118830009·The LapBox Tissue Containment Removal System is...

ARK™ Methotrexate Dilution Buffer

FDA UDI

ARK DIAGNOSTICS INC·00858724003209·The ARK™ Methotrexate Dilution Buffer is intend...

ARK™ Ketamine Assay (115mL)

FDA UDI

ARK DIAGNOSTICS INC·00812101030011·The ARK™ Ketamine Assay is intended for the qu...

ARK™ Tramadol Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003773·The ARK™ Tramadol Assay is intended for the qu...

ARK™ Meperidine Assay

FDA UDI

ARK DIAGNOSTICS INC·00812101030127·The ARK™ Meperidine Assay is intended for the ...

DRI™ Fentanyl II Cutoff Calibrator

FDA UDI

ARK DIAGNOSTICS INC·00812101030783·DRI™ Fentanyl II Cutoff Calibrator (Thermo Fish...

ARK™ Lacosamide Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003339·The ARK™ Lacosamide Assay is a homogeneous enz...

ARK™ Ethyl Glucuronide Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003629·The ARK™ Ethyl Glucuronide Assay is intended f...

ARK™ HS Benzodiazepine II 150/250ng/mL Control

FDA UDI

ARK DIAGNOSTICS INC·00812101030554·ARK™ HS Benzodiazepine II 150/250ng/mL Control ...

ARK™ Tramadol Assay (500mL)

FDA UDI

ARK DIAGNOSTICS INC·00858724003797·The ARK™ Tramadol Assay is intended for the qu...

ARK™ Pregabalin Urine Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003278·The ARK™ Pregabalin Urine Assay is a homogeneou...

ARK™ Zonisamide Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003018·The ARK™ Zonisamide Assay is a homogeneous enz...

ARK™ HS Benzodiazepine II 75/125ng/mL Control

FDA UDI

ARK DIAGNOSTICS INC·00812101030547·ARK™ HS Benzodiazepine II 75/125ng/mL Control i...

DRI™ Fentanyl II Negative Calibrator

FDA UDI

ARK DIAGNOSTICS INC·00812101030776·DRI™ Fentanyl II Negative Calibrator (Thermo Fi...

ARK™ UR-144/JWH-018 Negative Calibrator

FDA UDI

ARK DIAGNOSTICS INC·00812101030264·ARK™ UR-144/JWH-018 Negative Calibrator is inte...

ARK™ Oxcarbazepine Metabolite Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003308·The ARK™ Oxcarbazepine Metabolite Assay is a ho...

ARK™ Efavirenz Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003377·The ARK™ Efavirenz Assay is a homogeneous enzym...

ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator

FDA UDI

ARK DIAGNOSTICS INC·00812101030523·ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calib...