FDA Registration
Active
🇫🇮 Finland
AutoDELFIA Inhibin A kit (B064-112)
Reg #: 8043909
·
FEI: 3002808498
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WALLAC OY
- Registration Number
- 8043909
- FEI Number
- 3002808498
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- MUSTIONKATU 6
- City
- TURKU Varsinais-Suomi
- Country
- FI
Owner / Operator
- Firm Name
- Revvity, Inc.
- Operator Number
- 9912035
- Address
- 77 4th Avenue
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- Revvity, Inc.
- Contact Name
- Daniel Castellanos
- Address
- 77 4th Avenue
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
- [email protected]
- Phone
- 973 5808347
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Inhibin-A | NDR | Class 1 | Clinical Chemistry | No | 2015-03-09 |
Proprietary Names
AutoDELFIA Inhibin A kit (B064-112)
AutoDELFIA Inhibin A kit Level Calibrators (B064-112-P2)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device