Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003212362

FEI Number

3003212362

Entity Name

Nova Century Scientific

City/State/Country

Burlington Ontario, CA

Establishment Address

5022 South Service Road, Burlington Ontario L7L 5Y7, CA

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

IMMCO DIAGNOSTICS, INC. (Owner Number: 1315336)

Owner / Operator Contact Address

10 EARHART DR., --, Buffalo, NY 14221, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nova Century Scientific Urine Transport Vial (10ml & 30ml) Specimen Collection Swab

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHZ	Urine Transport Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2012-09-24
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-06-23

Official Correspondent

Lee Kroening

US Agent Details

Lee Kroening Business: Trinity Biotech Email: lee.kroening@trinitybiotech.com Phone: (716) 6910091

Related Public Records

Same Entity

IMMCO DIAGNOSTICS, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015376545	IMMCO DIAGNOSTICS, INC.	Williamsville, NY, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003212362. Last updated year: 2026. Please use registration number 3003212362 when referencing this establishment in official correspondence.