# COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.

FEI: 3009236726
Status: Active
Establishment types: Repack or Relabel Medical Device; Complaint File Establishment per 21 CFR 820.198
Owner/operator: Commonwealth Diagnostics Intl, Inc. (#10055546)

Address: 4 Technology Way, Salem, MA, US



## Products

Total registered: 1
Top product codes: NNI
Regulation §: 864.3250

Proprietary names: Hydrogen and Methane Breath Test Collection Kit: SIBO 10-Tube (Lactulose), Hydrogen Breath Test Collection Kit: Lactose 6-Tube, Hydrogen Breath Test Collection Kit: Fructose 6-Tube, Hydrogen Breath Test Collection Kit: Domestic SIBO 10-Tube (Lactulose), Hydrogen and Methane Breath Test Collection Kit: SIBO 10-Tube (Glucose), Hydrogen Breath Test Collection Kit: SIBO 10-Tube (Glucose), Hydrogen and Methane Breath Test Collection Kit: Fructose 6-Tube, Hydrogen Breath Test Collection Kit: Sucrose 6-Tube, Hydrogen Breath Test Collection Kit: Domestic SIBO 6-Tube (Lactulose), Hydrogen and Methane Breath Test Collection Kit: Sucrose 6-Tube

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223009236726%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3009236726