COPAN ITALIA

FDA Device Registration & Listing · BRESCIA Lombardy, IT · Registration 3002444944

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002444944
FEI Number
3002444944
Entity Name
COPAN ITALIA
City/State/Country
BRESCIA Lombardy, IT
Establishment Address
VIA F. PEROTTI, 10, 18, BRESCIA Lombardy 25125, IT
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Copan Liquid Amies ESwab BD ESwab Copan Liquid Amies Elution Swab HealthLink Elution Swab Xpert Swab Specimen Collection Kit BD BBL CultureSwab Plus BD BBL CultureSwab Copan Venturi Transystem Copan M40 Transystem HealthLink Transporter BHI (Brain Heart Infusion) Broth THIOBroth Copan M40 Transystem BD BBL CultureSwab Copan Venturi Transystem BD BBL CultureSwab Plus HealthLink Transporter BD BBL CultureSwab MaxV Cepheid Liquid Stuart Venturi Transystem HealthLink Transporter CultureSwab ALLIGENCE BD BBL CultureSwab Copan Venturi Transystem Liquid Stuarts Medium BD BBL CultureSwab Copan Venturi Transystem Cary-Blair Medium HealthLink Transporter Copan Viral Transystem BD FecalSwab Copan FecalSwab BD FCT Copan M40 Transystem Copan Venturi Transystem BD BBL CultureSwab Plus BD BBL CultureSwab HealthLink Transporter UriSponge UriSwab Xpert Urine Specimen Collection Kit Copan Easy-Swab Collection and Transport System BD BBL CultureSwab EZ Sample Diluent Tube Copan SLsolution Snot Buster Saline Solution 0.85% UriSponge-Urine Collection, Transport, and Preservation System MSwab Colibri Daily Verification Kit Colibri Colibri Primary Tube with Saline Colibri Primary Tube with Water Colibri Spreader Colibri Primary Tube for Vitek 2 Xpert Vaginal/Endocervical Specimen Collection Kit Xpert CT/NG Xpert Swab Specimen Collectin Kit Xpert Urine Specimen Collection Kit Hardy SpeedStreakers InfoLab Loops Dove Medical Supply Loops HealthLink Inc. Loops and Needles Inoculation Loops Inoculation Needles BD Inoculation Loops Inoculation Spreaders Troy Biologicals Loops and Needles Disposable Transfer Pipettes Transfer Pipettes Double Spreader Sputum Dipper UniVerse® dispensing tube UniVerse® Dispensing Tube - Bottle MSwab bag for UniVerse MDL UroSwab Urine Transport Container NuFoam Swab Rayon Fiber Swab, Sterile Nylon Fiber Swab, Sterile Cotton Fiber Swab, Sterile Polyester Fiber Swab, Sterile FLOQBrush Buccal Swab CLASSIQSwab Foam Swab, Sterile FLOQSwab BD BBL CultureSwab BD BBL CultureSwab Plus Copan M40 Transystem Copan Venturi Transystem HealthLink Transporter HealthLink UTM Cepheid Xpert Xpress Nasopharyngeal Collection Kit Copan Universal Transport Medium UTM-RT Quest Diagnostics VCM BD BBL UVT BD Universal Viral Transport WASP Loop Cleansing Solution Xpert Nasal Sample Collection Kit Xpert Nasopharyngeal Sample Collection Kit BD MAX CG/GC/TV GN Broth Rayon Fiber Swab, Non-Sterile Cotton Fiber Swab, Non-Sterile Polyester Fiber Swab, Non-Sterile Foam Swab, Non-Sterile Nylon Fiber Swab, Non-Sterile NuFoam Swab CLASSIQSwab FLOQSwab eNAT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JTX Transport Systems, Anaerobic Microbiology Class 1 866.2900 2006-07-20
JTW System, Transport, Aerobic Microbiology Class 1 866.2900 2006-07-20
PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Microbiology Class 2 866.3975 2022-05-03
JSL Culture Media, Anaerobic Transport Microbiology Class 1 866.2390 2008-01-08
JSG Culture Media, Non-Selective And Non-Differential Microbiology Class 1 866.2300 2011-03-01
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2008-01-08
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2008-01-08
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2008-01-08
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2008-01-08
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2015-04-23
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2015-04-23
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2008-01-08
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2018-04-03
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2018-04-03
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2018-06-27
JTW System, Transport, Aerobic Microbiology Class 1 866.2900 2005-11-25
PPM General Purpose Reagent Pathology Class 1 864.4010 2017-10-30
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2025-03-07
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2025-03-07
JTW System, Transport, Aerobic Microbiology Class 1 866.2900 2012-06-30
QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry Microbiology Class 2 866.3378 2024-01-24
QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Microbiology Class 2 866.3378 2024-01-24
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Microbiology Class 2 866.1645 2024-01-24
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
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 1995-03-27
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2005-07-07
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2005-11-23
JSL Culture Media, Anaerobic Transport Microbiology Class 1 866.2390 2008-01-08
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2008-01-08
JCB Detergent Pathology Class 1 864.4010 2015-12-09
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2018-01-11
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2018-03-09
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 2011-10-11
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2005-11-23
QBD Microbial Nucleic Acid Storage And Stabilization Device Microbiology Class 2 866.2950 2020-10-14

Official Correspondent

ELISABETTA ZANELLA

US Agent Details

FABRIZIO MAZZOCCHI Business: Copan Diagnostics, Inc. Email: fabrizio.mazzocchi@copangroup.com Phone: (951) 8376897

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
3017063217 COPAN Diagnostics, Inc. Carlsbad, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880142 Hardy Media TSA W/LEC. & TWEEN. 80 1988-03-30
K914894 Microtest VIRAPURE, CHLAMYPURE AND MYCOPURE 1991-12-18
K003761 Medical Packaging Corp. NAT - NUCLEIC ACID TRANSPORT 2001-05-31
K033458 Becton, Dickinson & CO BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST 2004-05-28
K112000 bioMerieux, Inc. VITEK 2 STREPTOCOCCUS PENICILLIN 2011-10-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0170-2015 Siemens Healthcare Diagnostics, Inc. 2
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002444944. Last updated year: 2026. Please use registration number 3002444944 when referencing this establishment in official correspondence.
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