Quantase, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 4
What Quantase, Ltd. makes
Quantase, Ltd. manufactures in vitro diagnostic tests for newborn screening, including kits for detecting total galactose, phenylalanine, and combined phenylalanine/galactose levels. These assays are designed for laboratory use to identify metabolic disorders such as phenylketonuria (PKU) and galactosemia.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These assays are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Quantase Phe/Gal Screening Assay Ref K984463
Regimes: 510(k) Registry: 510(k)Quantase Total Galactose Screening Assay Ref K990644
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quantase, Ltd. have in the registry?
The registry currently lists 4 devices for Quantase, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quantase, Ltd.'s devices?
Among its 4 most recently registered devices, Quantase, Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Quantase, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Quantase, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quantase, Ltd. in the registry?
The most recently registered devices listed for Quantase, Ltd. include QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT, QUANTASE PHE/GAL SCREENING ASSAY, QUANTASE TOTAL GALACTOSE SCREENING ASSAY and QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT.