# Access Bio, Inc. (manufacturer, Monroe Township, NJ): 1 new FDA device listing, incl. multi-analyte controls, all kinds (assayed)

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Access Bio, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Monroe Township, NJ, US |
| New listings | 1 |
| Devices | Multi-Analyte Controls, All Kinds (Assayed) |
| Product codes | JJY |
| Device classes | Class I |
| Medical specialties | Clinical Chemistry |
| Brand names | CareSuperb COVID-19/Flu A&B Antigen Combo External Control |
| First new listing | 2026-06-05 |
| Latest new listing | 2026-06-05 |
| FDA registration number | 3024756665 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- 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.