Tm Bioscience Corporation
CanadaFDA applicant, unverified
- Devices
- 2
What Tm Bioscience Corporation makes
Tm Bioscience Corporation manufactures the TAG-IT Cystic Fibrosis Kit, a diagnostic test designed for detecting cystic fibrosis mutations in genetic screening.
The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Tag-It Cystic Fibrosis Kit Ref DEN050004
Regimes: De Novo Registry: De NovoTag-It Cystic Fibrosis Kit Ref K060627
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tm Bioscience Corporation have in the registry?
The registry currently lists 2 devices for Tm Bioscience Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tm Bioscience Corporation's devices?
Among its 2 most recently registered devices, Tm Bioscience Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Tm Bioscience Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tm Bioscience Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tm Bioscience Corporation in the registry?
The most recently registered devices listed for Tm Bioscience Corporation include TAG-IT CYSTIC FIBROSIS KIT.