FDA Registration
Active
🇩🇪 Germany
VIRAMED BIOTECH AG
Reg #: 3004181478
·
FEI: 3004181478
·
Expires 2026
Products
3
Proprietary Names
8
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- VIRAMED BIOTECH AG
- Registration Number
- 3004181478
- FEI Number
- 3004181478
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BEHRINGSTRASSE 11
- City
- PLANEGG Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K163504
Owner / Operator
- Firm Name
- VIRAMED BIOTECH AG
- Operator Number
- 9062838
- Address
- BEHRINGSTRASSE 11, --
- City
- PLANEGG
- State
- DE-NOTA
- Postal Code
- D-82152
- Country
- DE
US Agent
- Business Name
- Viralab Inc
- Contact Name
- Leonard Rollins
- Address
- 1815 14th St. NW Suite D
- City
- Rochester
- State
- MN
- ZIP
- 55901
- Country
- US
- [email protected]
- Phone
- 507 2084044
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2017-11-27 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2014-01-23 |
| Antigen, B. Pertussis | GOX | Class 1 | Microbiology | No | 2004-04-16 |
Proprietary Names
Borrelia B31 ViraChip IgG Test Kit
ViraCam
ViraChip Reader
Borrelia All-In-One ViraChip Test Kit
BORDETELLA SPECIES VIRASTRIPE
Borrelia B31 IgM ViraStripe
Borrelia B31 ViraChip IgM Test Kit
Borrelia B31 IgG ViraStripe
Establishment Types
Manufacture Medical Device