FDA Registration
Active
🇦🇺 Australia
GROPEP BIOREAGENTS PTY LTD
Reg #: 3008723200
·
FEI: 3008723200
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GROPEP BIOREAGENTS PTY LTD
- Registration Number
- 3008723200
- FEI Number
- 3008723200
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 51 West Thebarton Road
- City
- Adelaide South Australia
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K141073
Owner / Operator
- Firm Name
- GroPep Bioreagents Pty Ltd
- Operator Number
- 10053206
- Address
- 51 West Thebarton Road
- City
- Adelaide
- State
- South Australia
- Postal Code
- 5031
- Country
- AU
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2016-11-10 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)