FDA Registration
Active
🇺🇸 United States
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)
Reg #: 3007118747
·
FEI: 3007118747
·
Expires 2025
Products
5
Proprietary Names
1
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
- K113439
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 |
|---|---|---|---|---|---|
| Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | NBS | Class 2 | Immunology | No | 2013-04-16 |
| Autoantibodies, Nuclear Body Protein, Sp100 | NUM | Class 2 | Immunology | No | 2013-04-16 |
| Autoantibodies, Nuclear Pore Glycoprotein Gp210 | NRI | Class 2 | Immunology | No | 2013-04-16 |
| Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | NIY | Class 2 | Immunology | No | 2013-04-16 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2013-04-16 |
Proprietary Names
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)
Establishment Types
Complaint File Establishment per 21 CFR 820.198