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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 1 of 4

Device	Model / Reference	Registries	Class	Status
ARK™ Fentanyl Assay	5031-0001-00	FDA UDI	Class II	Active
ARK™ Methotrexate II Dilution Buffer	5071-0004-00	EUDAMEDFDA UDI	U	Active
ARK™ Gabapentin Assay (c-pack)	5025-0001-01	FDA UDI	Class II	Unknown
ARK™ Efavirenz Assay	5017-0001-00	FDA UDI	N/A	Active
ARK™ Methotrexate II Assay	5071-0001-00	FDA UDI	U	Active
DRI Tramadol Assay - 500 mL	B40000350	FDA UDI	Class II	Active
ARK™ Pregabalin Urine Calibrator	5035-0002-00	FDA UDI	Class II	Active
ARK™ Oxcarbazepine Metabolite Calibrator	5032-0002-00	FDA UDI	Class II	Active
ARK™ Fentanyl Assay	5031-0001-01	FDA UDI	Class II	Active
ARK™ Methotrexate Assay (c-pack)	5026-0001-01	FDA UDI	U	Active
DRI Tramadol Assay - 115mL	B40000351	FDA UDI	Class II	Active
ARK™ Zonisamide Calibrator	5022-0002-00	FDA UDI	Class II	Active
ARK™ Methotrexate II Control	5071-0003-02	FDA UDI	U	Active
ARK™ Ethyl Glucuronide Negative Calibrator	5036-0005-01	FDA UDI	Class II	Active
ARK™ Fentanyl II Assay - 500mL (WPT)	5072-0001-00	FDA UDI	Class II	Active
ARK™ Fentanyl Negative Calibrator (WPT)	5052-0002-01	FDA UDI	Class II	Active
ARK™ Lacosamide Calibrator	5033-0002-00	FDA UDI	Class II	Active
ARK™ Lamotrigine Assay	5023-0001-00	FDA UDI	Class II	Active
ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator	5036-0002-03	FDA UDI	Class II	Active
ARK™ Zonisamide Assay	5022-0001-00	FDA UDI	Class II	Active
ARK™ Levetiracetam Assay	5024-0001-00	FDA UDI	Class II	Active
DRI Tramadol Control Kit	B40000354	FDA UDI	Class II	Active
ARK™ Ethyl Glucuronide Control (375/625)	5036-0006-00	FDA UDI	Class I	Active
ARK™ Hydrocodone Assay	5076-0001-02	FDA UDI	Class II	Active
ARK™ Voriconazole II Assay	5030-0001-01	FDA UDI	N/A	Active
ARK™ Zonisamide Control	5022-0003-00	FDA UDI	Class I	Active
ARK™ Ethyl Glucuronide Assay	5036-0004-01	FDA UDI	N/A	Active
DRI Tramadol Cutoff Calibrator Kit	B40000352	FDA UDI	Class II	Active
ARK™ Voriconazole II Control	5030-0003-01	FDA UDI	N/A	Active
ARK Levetiracetam II Assay	5070-0001-01	FDA UDI	Class II	Active
ARK™ Levetiracetam Control	5024-0003-00	FDA UDI	Class I	Active
ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator	5036-0005-03	FDA UDI	Class II	Active
ARK™ Topiramate Calibrator	5015-0002-00	FDA UDI	Class II	Active
ARK™ Methotrexate II Assay	5071-0001-01	FDA UDI	U	Active
DRI™ Fentanyl II Control	10028875	FDA UDI	Class I	Active
ARK™ Methotrexate II Control	5071-0003-01	FDA UDI	U	Active
ARK™ Methylphenidate Negative Calibrator	5042-0002-01	FDA UDI	Class II	Active
ARK™ Pregabalin Urine Assay	5035-0001-00	FDA UDI	Class II	Active
ARK™ Levetiracetam Calibrator	5024-0002-00	FDA UDI	Class II	Active
ARK™ Gabapentin Assay	5025-0001-00	FDA UDI	Class II	Active
ARK™ Fentanyl Assay - 500mL (WPT)	5052-0001-00	FDA UDI	Class II	Active
ARK™ Methotrexate II Calibrator	5071-0002-00	FDA UDI	U	Active
ARK™ Methotrexate Dilution Buffer	5026-0004-00	EUDAMEDFDA UDI	Class II	Active
DRI™ Fentanyl II Negative Calibrator	10028874	FDA UDI	Class II	Active
ARK™ Methotrexate Control	5026-0003-03	FDA UDI	Class I	Active
ARK™ Ethyl Glucuronide Assay	5036-0004-02	FDA UDI	N/A	Active
DRI Tramadol Negative Calibrator Kit	B40000353	FDA UDI	Class II	Active
ARK™ Methotrexate Assay	5026-0001-00	FDA UDI	U	Active
ARK™ Methotrexate Control	5026-0003-00	FDA UDI	Class I	Active
ARK™ Hydrocodone Control	5076-0003-00	FDA UDI	Class II	Active

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