FDA Device Establishments · JSON-LD · Markdown

COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.

FEI 3009236726 · Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number3009236726
Owner / OperatorCommonwealth Diagnostics Intl, Inc. (#10055546)
Address4 Technology Way, Salem, MA, US
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)NNI
Regulation § (21 CFR)864.3250
Proprietary namesHydrogen 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

External sources

Source: openFDA. Public-domain (CC0).