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Sign in to claim this brandARK 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
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Dionne Labatore
- EUDAMED SRN
- US-MF-000023925
- FDA FEI Number
- 3005755244
- DUNS Number
- —
Catalogue (183)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ARK Methotrexate Assay | K163359 | FDA 510(k) | U | Active |
| Ark Levetiracetam Assay, Ark Levetiracetam Calibrator And Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00 | K091653 | FDA 510(k) | Class II | Active |
| ARK Hydrocodone Assay | K231752 | FDA 510(k) | Class II | Active |
| ARK Voriconazole II Assay Test System | DEN160033 | FDA 510(k) | Class II | Active |
| Topiramate Assay, Ark Topiramate Calibrator And Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00 | K083799 | FDA 510(k) | Class II | Active |
| Ark Gabapentin Assay, Ark Gabepentin Califrator, And Ark Gabapentin Control Model5025-0001-00, 5025-0002-00, 5025-0003-0 | K101574 | FDA 510(k) | Class II | Active |
| Ark Zonisamide Assay, Ark Zonisamide Calibrator, And Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003 | K091884 | FDA 510(k) | Class II | Active |
| ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | K153596 | FDA 510(k) | Class II | Active |
| Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (calibration Ran | K111904 | FDA 510(k) | U | Active |
| Ark Lamotrigine Assay, Calibrator & Control | K101305 | FDA 510(k) | Class II | Active |
| ARK Levetiracetam II Assay | K232522 | FDA 510(k) | Class II | Active |
| ARK AB-PINACA Control | 5055-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Meperidine Calibrator | 5039-0002-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ethyl Glucuronide Calibrator | 5036-0002-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Assay | 5073-0001-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Pregabalin II Assay | 5059-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine Assay | 5056-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine II Control | 5083-0003-01 | EUDAMED | Class B | Active |
| ARK HS Benzodiazepine II Calibrator | 5073-0002-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine II Calibrator | 5083-0002-00 | EUDAMED | Class B | Active |
| ARK Ethyl Glucuronide II Assay | 5077-0001-01 | EUDAMED | Class B | Active |
| ARK UR-144/JWH-018 Assay | 5054-0001-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Meperidine Calibrator | 5039-0002-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ethyl Glucuronide Calibrator | 5036-0002-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ethyl Glucuronide Control | 5036-0003-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK EDDP Calibrator | 5051-0002-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine Control | 5056-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK EDDP Calibrator | 5051-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Zopiclone Control | 5043-0003-00 | EUDAMED | Class B | Active |
| ARK Zopiclone Assay | 5043-0001-00 | EUDAMED | Class B | Active |
| ARK Methylphenidate Metabolite Control | 5042-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Control | 5073-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Tramadol Control | 5040-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK EDDP Assay | 5051-0001-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Meperidine Control | 5039-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Tramadol Calibrator | 5040-0002-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Fentanyl Calibrator | 5031-0002-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine Calibrator | 5056-0002-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Tramadol Assay | 5040-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK AB-PINACA Calibrator | 5055-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Topiramate Assay | 5015-0001-00 | EUDAMEDFDA UDI | IVD General | Active |
| ARK Methylphenidate Metabolite Assay | 5042-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Fentanyl II Assay | 5069-0001-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Calibrator | 5073-0002-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ethyl Glucuronide Calibrator | 5036-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK EDDP Assay | 5051-0001-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK EDDP Control | 5051-0003-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine II Calibrator | 5083-0002-01 | EUDAMED | Class B | Active |
| ARK EDDP Calibrator | 5051-0002-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Assay | 5073-0001-01 | EUDAMEDFDA UDI | Class B | Active |
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