Bionetic Laboratory Products
Country not established
- Devices
- 8
What Bionetic Laboratory Products makes
Bionetic Laboratory Products manufactures diagnostic test kits and laboratory equipment for microbiological and serological analysis. Their offerings include immunofluorescence assay (IFA) and direct fluorescent antibody (DFA) kits for detecting pathogens such as *Legionella*, *Toxoplasma gondii*, and *Varicella-Zoster Virus* (VZV), as well as enzyme-linked immunosorbent assay (ELISA) systems for antibody detection. They also produce specialized incubators for bacterial culture and automated ELISA readers to streamline laboratory workflows.
The company’s products are regulated under the FDA’s 510(k) premarket notification process, with devices classified as Class I (general controls) and Class II (special controls). Their portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Legionella Ifa Kit I Ref K831760
Regimes: 510(k) Registry: 510(k)Lbi-100 37DEGREES Incubator Ref K830405
Regimes: 510(k) Registry: 510(k)Automated Elisa Reader Lbi 300 Ref K830227
Regimes: 510(k) Registry: 510(k)Amebiasis Bio-Enzabead Screen Kit Ref K831133
Regimes: 510(k) Registry: 510(k)Toxo Ipa Kit Ian Indirect Fluorescent Ref K832069
Regimes: 510(k) Registry: 510(k)Legionella Dfa Kit I Ref K830820
Regimes: 510(k) Registry: 510(k)Vzv Bio-Enzabead Screen Kit Ref K833637
Regimes: 510(k) Registry: 510(k)Immunoenzyme Test Sys-Detect-Igm Anti Ref K832900
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bionetic Laboratory Products have in the registry?
The registry currently lists 8 devices for Bionetic Laboratory Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionetic Laboratory Products's devices?
Among its 8 most recently registered devices, Bionetic Laboratory Products has devices listed in FDA 510(k) (8 devices).
What risk classes do Bionetic Laboratory Products's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Bionetic Laboratory Products's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionetic Laboratory Products in the registry?
The most recently registered devices listed for Bionetic Laboratory Products include LEGIONELLA IFA KIT I, LBI-100 37DEGREES INCUBATOR, AUTOMATED ELISA READER LBI 300 and AMEBIASIS BIO-ENZABEAD SCREEN KIT.