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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 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ARK Methylphenidate Metabolite Calibrator | 5042-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Meperidine Assay | 5039-0001-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Calibrator | 5073-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine Assay | 5056-0001-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine Calibrator | 5056-0002-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Zopiclone Calibrator | 5043-0002-02 | EUDAMED | Class B | Active |
| ARK Ethyl Glucuronide Control | 5036-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine II Calibrator | 5083-0002-02 | EUDAMED | Class B | Active |
| ARK Zopiclone Calibrator | 5043-0002-01 | EUDAMED | Class B | Active |
| ARK Tramadol Assay | 5040-0001-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Calibrator | 5073-0002-03 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Control | 5073-0003-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK HS Benzodiazepine II Assay | 5073-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Fentanyl II Assay | 5069-0001-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK UR-144/JWH-018 Assay | 5054-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK EDDP Assay | 5051-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine Calibrator | 5056-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Fentanyl II Assay | 5069-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ethyl Glucuronide Assay | 5036-0001-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK EDDP Control | 5051-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ethyl Glucuronide Assay | 5036-0001-01 | EUDAMEDFDA UDI | Class B | Active |
| ARK UR-144/JWH-018 Calibrator | 5054-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK AB-PINACA Assay | 5055-0001-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Methylphenidate Metabolite Calibrator | 5042-0002-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Pregabalin II Control | 5059-0003-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Tramadol Calibrator | 5040-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Meperidine Calibrator | 5039-0002-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ketamine II Control | 5083-0003-00 | EUDAMED | Class B | Active |
| ARK Ketamine II Assay | 5083-0001-02 | EUDAMED | Class B | Active |
| ARK Pregabalin II Calibrator | 5059-0002-00 | EUDAMEDFDA UDI | Class B | Active |
| ARK Ethyl Glucuronide II Assay | 5077-0001-00 | EUDAMED | Class B | Active |
| ARK Tramadol Assay | 5040-0001-02 | EUDAMEDFDA UDI | Class B | Active |
| ARK Meperidine Assay | 5039-0001-00 | EUDAMEDFDA UDI | Class B | Active |
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