Contract manufacturerMAXIM BIOMEDICAL INC. (Rockville, MD)MarylandClinical chemistryMicrobiologyClass IIClass I
MAXIM BIOMEDICAL INC.
Contract manufacturer ยท Rockville, MD
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1122236 (openFDA record; or search FDA's registration database)
- FEI number
- 1122236
- Registered for
- FDA registration year 2027
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- MAXIM BIOMEDICAL INC. (FDA owner/operator no. 9083027)
- Registered address
- 1500 E GUDE DR, STE A, Rockville, MD 20850
- Contract listings
- 4 device listings, 4 product codes, first listed May 12, 2023
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | Class II | Clinical chemistry | Contract manufacturing | Oct 8, 2026 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | May 12, 2023 |
| NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | Class I | Clinical chemistry | Contract manufacturing | May 12, 2023 |
| SBZ | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users | Class II | Microbiology | Contract manufacturing | Oct 8, 2026 |