FDA Registration
Active
🇩🇪 Germany
MagNA Pure 96 DNA Tissue Lysis Buffer
Reg #: 3013496958
·
FEI: 3013496958
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRODUKT SERVICE ERDT GMBH
- Registration Number
- 3013496958
- FEI Number
- 3013496958
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fritz-Haber-Str. 6
- City
- Viernheim Hesse
- Country
- DE
Owner / Operator
- Firm Name
- Produkt Service Erdt GmbH
- Operator Number
- 10052296
- Address
- Fritz-Haber-Strasse 6
- City
- Viernheim
- State
- Hesse
- Postal Code
- 68519
- Country
- DE
- Correspondent
- Torsten Kuehlwein
US Agent
- Business Name
- Roche Diagnostics Operations Inc
- Contact Name
- Brian Frazier
- Address
- 9115 Hague Rd
- City
- Indianapolis
- State
- IN
- ZIP
- 46256
- Country
- US
- [email protected]
- Phone
- 317 5214603
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2018-02-02 |
Proprietary Names
MagNA Pure 96 DNA Tissue Lysis Buffer
MagNA Pure 96 DNA and Viral NA SV Kit
MagNA Pure 96 Bacterial Lysis Buffer
MagNA Pure 96 DNA and Viral NA LV Kit
MagNA Pure 96 External Lysis Buffer
Establishment Types
Repack or Relabel Medical Device