FDA Registration
Active
🇺🇸 United States
A. Menarini Premier Hb9210 Assay Components
Reg #: 1931251
·
FEI: 1931251
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Trinity Biotech (Primus Corporation dba Trinity Biotech)
- Registration Number
- 1931251
- FEI Number
- 1931251
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4231 E 75th Terrace
- 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 |
Proprietary Names
A. Menarini Premier Hb9210 Assay Components
Premier Hb9210 HbA1c Assay Components
Establishment Types
Manufacture Medical Device