Data / Medical devices / United States / Copan Diagnostics, Inc.

Copan Diagnostics, Inc.: FDA-registered device maker in Murrieta, CA, United States, 2 510(k) clearances

Name: Copan Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Copan Diagnostics, Inc. is registered with the FDA (registration 2436875) in Murrieta, CA, United States. It lists 14 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 10, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2436875
FEI number: 1000521444
Address: 26055, 26083 & 26087 Jefferson Avenue, Murrieta, CA, United States, 92562
Owner or operator: COPAN ITALIA Spa (9016900)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: March 27, 1995
Registered through: 2026
Brand names listed: ACT Transfer Pipettes, AeroMed Transfer Pipettes, BC+, BD BBL UVT, BD FCT, BD FecalSwab, BD Inoculation Loops, BD Universal Viral Transport and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Culture Media, Non-Selective And Non-Differential	JSG	1	Manufacturer	accessdata.fda.gov
Culture Media, Selective Broth	JSD	1	Manufacturer	accessdata.fda.gov
Device, Specimen Collection	LIO	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, Chlamydia	MKZ	1	Contract manufacturer	accessdata.fda.gov
Dna-Reagents, Neisseria	LSL	2	Contract manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Kit, Quality Control For Culture Media	JTR	1	Repackager or relabeler	accessdata.fda.gov
Micro Pipette	JRC	1	Manufacturer	accessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization Device	QBD	2	Contract manufacturer	accessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	QEP	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2015	K142094	COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM	JSM	Substantially Equivalent	Copan Italia Spa	accessdata.fda.gov
December 7, 2004	K042970	COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM	JSM	Substantially Equivalent	Copan Diagnostics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 14, 2023	92832	Class II	Ongoing	COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.	Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance	accessdata.fda.gov

Compare with other makers

Updated September 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.