FDA Registration
Active
🇺🇸 United States
Trinity Biotech (Primus Corporation dba Trinity Biotech)
Reg #: 1931251
·
FEI: 1931251
·
Expires 2026
Products
3
Proprietary Names
10
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Trinity Biotech (Primus Corporation dba Trinity Biotech)
- Registration Number
- 1931251
- FEI Number
- 1931251
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4231 E 75th Ter
- City
- KANSAS CITY
- State
- MO
- ZIP
- 64132
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112015
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 |
|---|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2012-02-09 |
| Abnormal Hemoglobin Quantitation | GKA | Class 2 | Hematology | No | 2023-08-30 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2021-09-08 |
Proprietary Names
A. Menarini Premier Hb9210 Assay Components
Premier Hb9210 HbA1c Assay Components
Premier Resolution Analyzer
Premier Resolution Assay Components
TRI-stat 2 Analyzer
TRI-stat Assay Components
ultra2 Genesys Variants Analyzer
ultra2 Resolution Variants Assay Components
ultra2 Resolution Variants Analyzer
ultra2 Genesys Variants Assay Components
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only