# ALFA WASSERMANN

FEI: 1000122044
Status: Active
Establishment types: Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Owner/operator: Alfa Wassermann Diagnostic Technologies, LLC (#10028192)

Address: 4 Henderson Dr, West Caldwell, NJ, US



## Products

Total registered: 4
Top product codes: MRR, CHH, LBS, CDT
Regulation §: 862.1475, 862.1175, 862.1705

Proprietary names: ACE LDL-C Reagent (plasma), ACE Triglycerides Reagent (plasma), ACE Cholesterol Reagent (plasma), ACE HDL-C Reagent (plasma)

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%221000122044%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=1000122044