Centers For Disease Control And Prevention
Country not established FDA establishment FEI 1050190
- Devices
- 39
- Registrations
- FDA
- FDA recalls
- 1
What Centers For Disease Control And Prevention makes
The company develops and provides diagnostic assays for infectious diseases, including real-time PCR tests for *Bacillus anthracis*, *Dengue virus* (DENV-1-4), and orthopoxviruses, as well as serological tests for antinuclear antibodies and *Legionella* infections. It also offers influenza diagnostic panels for typing, subtyping, and lineage genotyping of Influenza A and B viruses, including specialized kits for H5 and H7 subtypes.
These assays are regulated under FDA Class II and Class III devices, with submissions recorded via 510(k) clearances and Premarket Approval Applications (PMA). The company’s products are listed in the FDA’s regulatory databases and are based in the United States.
Catalogue
Search and filter all 39 devicesCompany details
- FDA FEI number
- 1050190
- Address
- 1600 CLIFTON RD., N.E., ATLANTA, GA, 30333
FDA recalls
FDA recall records list 1 recall initiated by CENTERS FOR DISEASE CONTROL AND PREVENTION, initiated on 2024-04-26. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. 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 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 26 Apr 2024 Z-2220-2024 Class II Terminated The H5b component may fail to amplify, resulting in an inconclusive result.
Frequently asked questions
How many devices does CENTERS FOR DISEASE CONTROL AND PREVENTION have in the registry?
The registry currently lists 39 devices for CENTERS FOR DISEASE CONTROL AND PREVENTION. Devices recorded under merged duplicate company entries are counted once.
Which registries list CENTERS FOR DISEASE CONTROL AND PREVENTION's devices?
Among its 39 most recently registered devices, CENTERS FOR DISEASE CONTROL AND PREVENTION has devices listed in FDA 510(k) (38 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CENTERS FOR DISEASE CONTROL AND PREVENTION's devices fall under?
Among its 39 most recently registered devices, the classes recorded for CENTERS FOR DISEASE CONTROL AND PREVENTION's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for CENTERS FOR DISEASE CONTROL AND PREVENTION?
FDA recall records list 1 recall initiated by CENTERS FOR DISEASE CONTROL AND PREVENTION, the most recent initiated on 2024-04-26. 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 CENTERS FOR DISEASE CONTROL AND PREVENTION in the registry?
The most recently registered devices listed for CENTERS FOR DISEASE CONTROL AND PREVENTION include B. anthracis Real-time PCR Assay, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Rickettsia Real-time PCR Assay and SERA FOR ANTINUCLEAR ANTIBODIES.