Is this your brand? Sign in to claim ownership.

ARK DIAGNOSTICS INC

United States·US-MF-000023925

Last updated September 17, 2026

Information

Country: United States
Address: 48089, Fremont Blvd., Fremont, United States
Website: www.ark-tdm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Dionne Labatore
EUDAMED SRN: US-MF-000023925
FDA FEI Number: 3005755244
DUNS Number: —

Catalogue (183)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
ARK™ Ethyl Glucuronide Assay	5036-0004-00	FDA UDI	N/A	Active
ARK™ Methotrexate Assay	5026-0001-02	FDA UDI	U	Active
ARK™ Oxcarbazepine Metabolite Assay	5032-0001-00	FDA UDI	Class II	Active
ARK™ Hydrocodone Assay	5076-0001-00	FDA UDI	Class II	Active
ARK™ Methotrexate Assay	5026-0001-03	FDA UDI	U	Active
ARK™ Methotrexate Control	5026-0003-01	FDA UDI	Class I	Active
ARK™ Efavirenz Calibrator	5017-0002-00	FDA UDI	N/A	Active
ARK™ Ethyl Glucuronide Calibrator	5036-0005-00	FDA UDI	Class II	Active
ARK™ Lacosamide Assay	5033-0001-00	FDA UDI	N/A	Active
ARK™ Methotrexate Control	5026-0003-02	FDA UDI	Class I	Active
ARK™ Methotrexate Calibrator	5026-0002-00	FDA UDI	Class II	Active
ARK™ Hydrocodone Calibrator Negative	5076-0002-01	FDA UDI	Class II	Active
ARK™ Pregabalin Urine Control	5035-0003-00	FDA UDI	Class I	Active
ARK™ Ethyl Glucuronide 500 Cutoff Calibrator	5036-0005-02	FDA UDI	Class II	Active
ARK™ Levetiracetam II Calibrator	5070-0002-00	FDA UDI	Class II	Active
ARK™ Ethyl Glucuronide Control (750/1250)	5036-0006-01	FDA UDI	Class I	Active
ARK™ Lamotrigine Calibrator	5023-0002-00	FDA UDI	Class II	Active
ARK™ Lamotrigine Control	5023-0003-00	FDA UDI	Class I	Active
ARK™ Hydrocodone Calibrator Cutoff	5076-0002-02	FDA UDI	Class II	Active
ARK™ Hydrocodone Calibrator	5076-0002-00	FDA UDI	Class II	Active
DRI™ Fentanyl II Cutoff Calibrator	10028873	FDA UDI	Class II	Active
ARK™ Voriconazole II Calibrator	5030-0002-01	FDA UDI	N/A	Active
ARK™ Lacosamide Control	5033-0003-00	FDA UDI	Class I	Active
ARK™ Fentanyl Control (WPT)	5052-0003-00	FDA UDI	Class I	Active
ARK™ Levetiracetam II Control	5070-0003-00	FDA UDI	Class II	Active
ARK™ Hydrocodone Assay	5076-0001-01	FDA UDI	Class II	Active
ARK™ Topiramate Control	5015-0003-00	FDA UDI	Class I	Active
ARK™ Gabapentin Calibrator	5025-0002-00	FDA UDI	Class II	Active
ARK™ Methotrexate II Control	5071-0003-00	FDA UDI	U	Active
DRI™ Fentanyl II Assay - 500mL	10028871	FDA UDI	Class II	Active
DRI™ Fentanyl II Assay	10028872	FDA UDI	Class II	Active
ARK™ Oxcarbazepine Metabolite Control	5032-0003-00	FDA UDI	Class I	Active
DRI Tramadol Calibrator Kit	B40000366	FDA UDI	Class II	Active
ARK™ Levetiracetam II Assay	5070-0001-00	FDA UDI	Class II	Active
ARK™ Fentanyl Assay - 500mL	5031-0001-02	FDA UDI	Class II	Active
ARK™ Fentanyl Calibrator	5031-0002-00	FDA UDI	Class II	Active
ARK™ Gabapentin Control	5025-0003-00	FDA UDI	Class I	Active
ARK™ Fentanyl Cutoff Calibrator (WPT)	5052-0002-02	FDA UDI	Class II	Active
ARK™ Efavirenz Control	5017-0003-00	FDA UDI	N/A	Active
ARK Fentanyl Control	5031-0003-00	EUDAMEDFDA UDI	Class B	Active
ARK UR-144/JWH-018 Calibrator	5054-0002-01	EUDAMEDFDA UDI	Class B	Active
ARK AB-PINACA Calibrator	5055-0002-01	EUDAMEDFDA UDI	Class B	Active
ARK Pregabalin II Assay	5059-0001-01	EUDAMEDFDA UDI	Class B	Active
ARK EDDP Calibrator	5051-0002-03	EUDAMEDFDA UDI	Class B	Active
ARK UR-144/JWH-018 Control	5054-0003-00	EUDAMEDFDA UDI	Class B	Active
ARK Tramadol Calibrator	5040-0002-00	EUDAMEDFDA UDI	Class B	Active
ARK Ethyl Glucuronide Assay	5036-0001-00	EUDAMEDFDA UDI	Class B	Active
ARK Fentanyl Calibrator	5031-0002-02	EUDAMEDFDA UDI	Class B	Active
ARK Lacosamide Assay	K201089	FDA 510(k)	Class II	Active
ARK Methotrexate II Assay	K232017	FDA 510(k)	U	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.