FDA Registration
Active
🇺🇸 United States
MAXIM BIOMEDICAL INC.
Reg #: 1122236
·
FEI: 1122236
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- MAXIM BIOMEDICAL INC.
- Registration Number
- 1122236
- FEI Number
- 1122236
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1500 E GUDE DR, STE A
- City
- Rockville
- State
- MD
- ZIP
- 20850
- Country
- US
Owner / Operator
- Firm Name
- MAXIM BIOMEDICAL INC.
- Operator Number
- 9083027
- Address
- 1500 EAST GUDE DR., SUITE A, --
- City
- Rockville
- State
- MD
- Postal Code
- 20850
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2023-09-12 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-05-12 |
| Immunoassay For Detection Of Amniotic Fluid Protein(S). | NQM | Class 1 | Clinical Chemistry | No | 2023-05-12 |
Proprietary Names
MaximBio ClearDetect COVID-19 Antigen Home Test
ROM Plus Rupture of Membrane Test
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)