FDA Registration
Active
🇫🇮 Finland
DELFIA Wash Concentrate (PN B117-100, 1244-114, 4010-0010)
Reg #: 8043909
·
FEI: 3002808498
·
Expires 2025
Products
1
Proprietary Names
7
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 |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2016-08-21 |
Proprietary Names
DELFIA Wash Concentrate (PN B117-100, 1244-114, 4010-0010)
DELFIA Diluent 2 (B131-100, B132-100, B138-100)
DELFIA Enhancement Solution (B118-100, 1244-104, 1244-105)
DELFIA Inducer (3304-0010)
DELFIA Diluent 3 (4021-0010, 4022-0010)
GSP Wash Concentrate (4080-0010)
Buffer M (4402-0010)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device