FDA Registration
Active
🇺🇸 United States
Infliximab Test System
Reg #: 2431980
·
FEI: 2431980
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CHEMBIO DIAGNOSTIC SYSTEMS, INC.
- Registration Number
- 2431980
- FEI Number
- 2431980
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3661 HORSEBLOCK RD.
- City
- MEDFORD
- State
- NY
- ZIP
- 11763
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN210056
Owner / Operator
- Firm Name
- CHEMBIO DIAGNOSTIC SYSTEMS, INC.
- Operator Number
- 2431980
- Address
- 3661 HORSEBLOCK RD., --
- City
- MEDFORD
- State
- NY
- Postal Code
- 11763
- Country
- US
- Correspondent
- THOMAS D IPPOLITO
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Infliximab Test System | QXT | Class 2 | Clinical Toxicology | No | 2025-02-27 |
Proprietary Names
Infliximab Test System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device