Springwood Microbiologicals
Country not established
- Devices
- 2
What Springwood Microbiologicals makes
Springwood Microbiologicals manufactures fluorescent antibody conjugates used for identifying specific pathogens in clinical samples. These include conjugates for detecting influenza A virus (GP.A) and Legionella species, designed for laboratory testing and diagnostic purposes.
The company’s products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I and Class II. These conjugates are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Fluorescent Antibody Conjugate For Gp.a Ref K812013
Regimes: 510(k) Registry: 510(k)Direct Fa Conjugate For Legionella Sp Ref K813339
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Springwood Microbiologicals have in the registry?
The registry currently lists 2 devices for Springwood Microbiologicals. Devices recorded under merged duplicate company entries are counted once.
Which registries list Springwood Microbiologicals's devices?
Among its 2 most recently registered devices, Springwood Microbiologicals has devices listed in FDA 510(k) (2 devices).
What risk classes do Springwood Microbiologicals's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Springwood Microbiologicals's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Springwood Microbiologicals in the registry?
The most recently registered devices listed for Springwood Microbiologicals include FLUORESCENT ANTIBODY CONJUGATE FOR GP.A and DIRECT FA CONJUGATE FOR LEGIONELLA SP.