FDA Registration
Active
🇺🇸 United States
IDS-iSYS Intact PTH
Reg #: 3007118747
·
FEI: 3007118747
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- EUROIMMUN US INC.
- Registration Number
- 3007118747
- FEI Number
- 3007118747
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1 Bloomfield Ave
- City
- Mountain Lakes
- State
- NJ
- ZIP
- 07046
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103325
Owner / Operator
- Firm Name
- EUROIMMUN US Inc.
- Operator Number
- 10025673
- Address
- 1 Bloomfield Ave.
- City
- Mountain Lakes
- State
- NJ
- Postal Code
- 07046
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2023-08-04 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2023-08-04 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-08-04 |
Proprietary Names
IDS-iSYS Intact PTH
IDS-iSYS Intact PTH Calibration Verifiers
IDS-iSYS Intact PTH Control Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198