Opgen, Inc.
Country not established
- Devices
- 19
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Opgen, Inc. makes
Opgen, Inc. manufactures the Acuitas AMR Gene Panel, a diagnostic test designed to detect antimicrobial resistance genes in bacterial samples, aiding in targeted infection management.
The company’s portfolio is regulated under Class II devices in the United States, with the Acuitas AMR Gene Panel authorised via the FDA’s 510(k) pathway. The company is based in the US.
Catalogue
Search and filter all 19 devicesCompany details
- DUNS number
- 119234263
- [email protected]
- Phone
- 301-869-9683
FDA recalls
FDA recall records list 2 recalls initiated by Opgen, Inc., the earliest on 2018-05-14 and the most recent on 2019-03-18. By recorded status: 2 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 18 Mar 2019 Z-1328-2019 Class II Terminated May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
2018
- 14 May 2018 Z-2439-2018 Class II Terminated Possible diminished performance prior to its established expiration date.
Frequently asked questions
How many devices does Opgen, Inc. have in the registry?
The registry currently lists 19 devices for Opgen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opgen, Inc.'s devices?
Among its 19 most recently registered devices, Opgen, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Opgen, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Opgen, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Opgen, Inc.?
FDA recall records list 2 recalls initiated by Opgen, Inc., the most recent initiated on 18 Mar 2019. 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 Opgen, Inc. in the registry?
The most recently registered devices listed for Opgen, Inc. include Acuitas CP3233, Acuitas KT03U01-2, Acuitas CP3511 and Acuitas CP3230.