Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009236726

FEI Number

3009236726

Entity Name

COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.

City/State/Country

Salem, MA, US

Establishment Address

4 Technology Way, Salem, MA 01970, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Commonwealth Diagnostics Intl, Inc. (Owner Number: 10055546)

Owner / Operator Contact Address

4 Technology Way, Salem, MA 01970, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2018-05-09

Official Correspondent

Gray Rifkin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Commonwealth Diagnostics Intl, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009236726. Last updated year: 2026. Please use registration number 3009236726 when referencing this establishment in official correspondence.