FDA Registration
Active
🇺🇸 United States
EUROLINE ENA Profile 9 Ag (IgG)
Reg #: 3007118747
·
FEI: 3007118747
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
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
- K140224
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 |
|---|---|---|---|---|---|
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2014-12-12 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2014-12-12 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2014-12-12 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2014-12-12 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2014-12-12 |
Proprietary Names
EUROLINE ENA Profile 9 Ag (IgG)
EUROLINE ENA ProfilePlus 4 (IgG)
Establishment Types
Complaint File Establishment per 21 CFR 820.198