FDA Registration
Active
🇺🇸 United States
Level 1 & Level 2 Controls
Reg #: 2247288
·
FEI: 1000122044
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- ALFA WASSERMANN
- Registration Number
- 2247288
- FEI Number
- 1000122044
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4 Henderson Dr
- City
- West Caldwell
- State
- NJ
- ZIP
- 07006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K930104
Owner / Operator
- Firm Name
- Alfa Wassermann Diagnostic Technologies, LLC
- Operator Number
- 10028192
- Address
- 4 Henderson Drive
- City
- West Caldwell
- State
- NJ
- Postal Code
- 07006
- Country
- US
- Correspondent
- Allan Gennis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2009-01-27 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2009-01-27 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2009-01-27 |
Proprietary Names
Level 1 & Level 2 Controls
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility