# Ark Diagnostics Inc (manufacturer, Fremont, CA): 2 new FDA device listings, incl. anti-factor xa activity test system, apixaban

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Ark Diagnostics Inc |
| Owner / operator | ARK Diagnostics Inc |
| Role | Manufacturer |
| Establishment types | Manufacture Device in the United States for Export Only |
| Location | Fremont, CA, US |
| New listings | 2 |
| Devices | Anti-Factor Xa Activity Test System, Apixaban; Enzyme Immunoassay, Benzodiazepine |
| Product codes | QLU, JXM |
| Device classes | Class II |
| Medical specialties | Hematology, Clinical Toxicology |
| Brand names | ARK Apixaban Control; ARK Apixaban Calibrator; ARK Apixaban Assay; ARK™ Zopiclone Assay; ARK™ Zopiclone Control; ARK™ Zopiclone Calibrator |
| First new listing | 2026-09-01 |
| Latest new listing | 2026-09-11 |
| FDA registration number | 3005755244 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.