FDA Registration
Active
🇺🇸 United States
P-595-B Trigger Solution B
Reg #: 2032839
·
FEI: 3004185580
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EPITOPE DIAGNOSTICS, INC.
- Registration Number
- 2032839
- FEI Number
- 3004185580
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7110 Carroll Rd
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Owner / Operator
- Firm Name
- EPITOPE DIAGNOSTICS, INC.
- Operator Number
- 9059077
- Address
- 7110 CARROLL RD, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- PING - GAO
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2024-11-14 |
Proprietary Names
P-595-B Trigger Solution B
P-595 Trigger Solution A and B
P-594 Wash Reagent
30669 Fecal Extraction Buffer
P-595-A Trigger Solution A
CL012 Light Check Solution
Establishment Types
Manufacture Medical Device