Id-Fish Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Id-Fish Technology, Inc. makes
Id-Fish Technology, Inc. manufactures immunoassay test kits for detecting Lyme disease antibodies (IgG and IgM) and Plasmodium genus/malaria species-specific nucleic acids. These products include blot-based serology tests for Lyme disease and molecular diagnostic kits for malaria parasite identification.
The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) pathway. These products are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
iDart Lyme IgG ImmunoBlot Kit Ref K233367
Regimes: 510(k) Registry: 510(k)iDart Lyme IgM ImmunoBlot Kit Ref K242872
Regimes: 510(k) Registry: 510(k)ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit Ref DEN160025
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Id-Fish Technology, Inc. have in the registry?
The registry currently lists 3 devices for Id-Fish Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Id-Fish Technology, Inc.'s devices?
Among its 3 most recently registered devices, Id-Fish Technology, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Id-Fish Technology, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Id-Fish Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Id-Fish Technology, Inc. in the registry?
The most recently registered devices listed for Id-Fish Technology, Inc. include iDart Lyme IgG ImmunoBlot Kit, iDart Lyme IgM ImmunoBlot Kit and ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit.