# Inova Diagnostics, Inc. (manufacturer, San Diego, CA): 3 new FDA device listings, incl. system, test, anticardiolipin immunological

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Inova Diagnostics, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Repack or Relabel Medical Device |
| Location | San Diego, CA, US |
| New listings | 3 |
| Devices | System, Test, Anticardiolipin Immunological; System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi); System, Multipurpose For In Vitro Coagulation Studies |
| Product codes | MID, MSV, JPA |
| Device classes | Class II |
| Medical specialties | Immunology, Hematology |
| Brand names | Aptiva APS IgA Reagent; BIO-FLASH Screw Caps for Sample Cups; BIO-FLASH Sample Racks Adapters; BIO-Flash Sample Racks; BIO-FLASH High Capacity Rinse Accessory; BIO-FLASH Waste Bottle; BIO-FLASH Triggers; BIO-FLASH |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-06-23 |
| FDA registration number | 2026994 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- 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: 2026-11-04T21:52:36.524Z.
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.