Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2436875

FEI Number

1000521444

Entity Name

COPAN DIAGNOSTICS, INC.

City/State/Country

Murrieta, CA, US

Establishment Address

26055, 26083 & 26087 Jefferson Avenue, Murrieta, CA 92562, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

GN Broth SELENITEBroth LIMBroth TSBBroth with Salt CABroth CryoBank Xpert Vaginal/Endocervical Specimen Collection Kit Xpert CT/NG Xpert Swab Specimen Collectin Kit Xpert Urine Specimen Collection Kit Cepheid Xpert Urine Specimen Collection Kit Sample Diluent Tube Copan SLsolution Snot Buster Saline Solution 0.85% BHI (Brain Heart Infusion) Broth THIOBroth Transfer Pipettes ACT Transfer Pipettes InfoLab Transfer Pipettes AeroMed Transfer Pipettes HealthLink UTM Cepheid Xpert Xpress Nasopharyngeal Collection Kit Copan Universal Transport Medium UTM-RT Quest Diagnostics VCM BD BBL UVT BD Universal Viral Transport Xpert Urine Specimen Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSD	Culture Media, Selective Broth	Microbiology	Class 1	866.2360	2011-03-01
JTR	Kit, Quality Control For Culture Media	Microbiology	Class 1	866.2480	2005-01-06
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2019-05-28
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2019-05-28
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2019-05-28
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2019-05-28
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2019-02-19
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2017-10-30
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2011-03-01
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2009-11-16
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2008-01-08
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2018-06-27

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
3009288740	Copan WASP	Brescia Lombardy, IT
3017063217	COPAN Diagnostics, Inc.	Carlsbad, CA, US
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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31

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9680687	CHROMAGAR	Saint-Denis Seine-Saint-Denis, FR
1114298	LONZA WALKERSVILLE, INC.	WALKERSVILLE, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2436875. Last updated year: 2026. Please use registration number 2436875 when referencing this establishment in official correspondence.