FDA Registration
Active
🇺🇸 United States
Captia Measles IgM ELISA Test Kit
Reg #: 1318354
·
FEI: 1318354
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Trinity Biotech USA
- Registration Number
- 1318354
- FEI Number
- 1318354
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2823 Girts Rd
- City
- Jamestown
- State
- NY
- ZIP
- 14701
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140455
Owner / Operator
- Firm Name
- TRINITY BIOTECH, PLC
- Operator Number
- 9025161
- Address
- 2823 Girts Rd
- City
- Jamestown
- State
- NY
- Postal Code
- 14701
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | PCL | Class 1 | Microbiology | No | 2014-09-17 |
Proprietary Names
Captia Measles IgM ELISA Test Kit
Establishment Types
Manufacture Medical Device