# Maxim Biomedical Inc. (contract manufacturer, Rockville, MD): 2 new FDA device listings, incl. visual, pregnancy hcg, prescription use

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Maxim Biomedical Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Rockville, MD, US |
| New listings | 2 |
| Devices | Visual, Pregnancy Hcg, Prescription Use; Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users |
| Product codes | JHI, SBZ |
| Device classes | Class II |
| Medical specialties | Clinical Chemistry, Microbiology |
| First new listing | 2026-10-08 |
| Latest new listing | 2026-10-08 |
| FDA registration number | 1122236 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.

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.