Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Country not established
- Devices
- 5
What Wallac Oy, A Subsidiary of Perkinelmer, Inc. makes
Wallac Oy manufactures diagnostic test kits for neonatal screening, including the GSP Neonatal Thyroxine (T4) assay and the Autodelphia Neonatal Immunoreactive Tryptophan (IRT) kit. These products are designed to measure thyroid function and detect congenital hypothyroidism in newborns.
The company’s portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory frameworks and are based in the United States.
Catalogue
Gsp Neonatal Total Galactose Kit Ref K133652
Regimes: 510(k) Registry: 510(k)Gsp Neonatal Thyroxine (T4) Ref K103484
Regimes: 510(k) Registry: 510(k)NeoLSD MSMS kit Ref K173829
Regimes: CE IVDR CE IVDD 510(k) Registry: 510(k)Gsp Neonatal Irt Kit (3306-001U) Ref K102419
Regimes: CE IVDD 510(k) Registry: EUDAMED510(k)Autodelfia Neonatal Irt Kit Ref K110274
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wallac Oy, A Subsidiary of Perkinelmer, Inc. have in the registry?
The registry currently lists 5 devices for Wallac Oy, A Subsidiary of Perkinelmer, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wallac Oy, A Subsidiary of Perkinelmer, Inc.'s devices?
Among its 5 most recently registered devices, Wallac Oy, A Subsidiary of Perkinelmer, Inc. has devices listed in EUDAMED (1 device) and FDA 510(k) (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Wallac Oy, A Subsidiary of Perkinelmer, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Wallac Oy, A Subsidiary of Perkinelmer, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wallac Oy, A Subsidiary of Perkinelmer, Inc. in the registry?
The most recently registered devices listed for Wallac Oy, A Subsidiary of Perkinelmer, Inc. include GSP NEONATAL TOTAL GALACTOSE KIT, GSP NEONATAL THYROXINE (T4), NeoLSD MSMS kit and GSP NEONATAL IRT KIT (3306-001U).