Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017063217

FEI Number

3017063217

Entity Name

COPAN Diagnostics, Inc.

City/State/Country

Carlsbad, CA, US

Establishment Address

2728 Loker Ave. W, Carlsbad, CA 92010, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COPAN ITALIA Spa (Owner Number: 9016900)

Owner / Operator Contact Address

Via F. Perotti 10, 18, Brescia, IT-BS 25125, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Copan Universal Transport Medium (UTM-RT) System Sample Diluent Tube Copan SLsolution Snot Buster Saline Solution 0.85%

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2024-11-04
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2024-11-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2017-10-30

Official Correspondent

ELISABETTA ZANELLA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COPAN ITALIA Spa

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015441043	Copan Industries, Inc.	Aguadilla, PR, US
2436875	COPAN DIAGNOSTICS, INC.	Murrieta, CA, US
3009288740	Copan WASP	Brescia Lombardy, IT
3002444944	COPAN ITALIA	BRESCIA Lombardy, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017063217. Last updated year: 2026. Please use registration number 3017063217 when referencing this establishment in official correspondence.