Copan Diagnostics, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1000521444
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Catalogue
Copan Viral Transystem Ref K001780
Regimes: 510(k) Registry: 510(k)Copan Venturi Transystem Liquid Amies Medium Ref K946288
Regimes: 510(k) Registry: 510(k)Copan Easy-Swab Collection And Transport System Ref K993161
Regimes: 510(k) Registry: 510(k)Copan Venturi Transystem Liquid Stuarts Medium Ref K946283
Regimes: 510(k) Registry: 510(k)Copan Venturi Transystem Stuarts Medium Ref K946285
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Copan Universal Transport Medium (Utm-Rt) System Ref K042970
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Copan Venturi Transystem Cary-Blair Medium Ref K946286
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000521444
- Address
- 26055, 26083 & 26087 Jefferson Avenue, Murrieta, CA, 92562
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 14 Jul 2023 Z-2620-2023 Class II Ongoing Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance
Frequently asked questions
How many devices does COPAN DIAGNOSTICS, INC. have in the registry?
The registry currently lists 10 devices for COPAN DIAGNOSTICS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list COPAN DIAGNOSTICS, INC.'s devices?
Among its 10 most recently registered devices, COPAN DIAGNOSTICS, INC. has devices listed in FDA 510(k) (10 devices).
What risk classes do COPAN DIAGNOSTICS, INC.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for COPAN DIAGNOSTICS, INC.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for COPAN DIAGNOSTICS, INC.?
FDA recall records list 1 recall initiated by COPAN DIAGNOSTICS, INC., the most recent initiated on 2023-07-14. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from COPAN DIAGNOSTICS, INC. in the registry?
The most recently registered devices listed for COPAN DIAGNOSTICS, INC. include COPAN VIRAL TRANSYSTEM, COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM, COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM and COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM.