Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021562175

FEI Number

3021562175

Entity Name

THE BIRD AND BE CO. INC.

City/State/Country

Toronto Ontario, CA

Establishment Address

73552 Wychwood PO, Toronto Ontario M6C1C0, CA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

The Bird and Be Co US Inc. (Owner Number: 10084250)

Owner / Operator Contact Address

630 Janet Avenue, Suite A100-b, Lancaster, PA 17601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ovulation Tests Ovarian Reserve Screening Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2022-01-30
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2023-12-10

Official Correspondent

Samantha Diamond

US Agent Details

David Kern Business: K2 Regulatory Consulting, LLC Email: dkern@k2regulatory.com Phone: (650) 8888251

Related Public Records

Same Entity

The Bird and Be Co US Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021562175. Last updated year: 2026. Please use registration number 3021562175 when referencing this establishment in official correspondence.