FDA Registration
Active
🇺🇸 United States
HIV SURE CHECK
Reg #: 3026565854
·
FEI: 3026565854
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Chembio Diagnostic Systems
- Registration Number
- 3026565854
- FEI Number
- 3026565854
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1560 Fifth Avenue
- City
- Bay Shore
- State
- NY
- ZIP
- 11706
- Country
- US
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 |
|---|---|---|---|---|---|
| Kit, Test, Saliva, Hiv-1&2 | MWB | Class 3 | Unknown | No | 2007-12-10 |
Proprietary Names
HIV SURE CHECK
HIV DIPSTICK
HIV STAT PAK
DPP HIV
Establishment Types
Manufacture Device in the United States for Export Only