Turklab Medical Devices, Inc.
TürkiyeFDA applicant, unverified
- Devices
- 1
What Turklab Medical Devices, Inc. makes
Turklab Medical Devices, Inc. manufactures rapid diagnostic tests for early pregnancy detection, including the RAPIDAN OPTIMA and TOYO pregnancy test kits. These devices provide qualitative results to confirm pregnancy via urine samples, designed for home or point-of-care use.
The company’s products are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Turklab Medical Devices, Inc. have in the registry?
The registry currently lists 1 device for Turklab Medical Devices, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Turklab Medical Devices, Inc.'s devices?
Among its 1 most recently registered device, Turklab Medical Devices, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Turklab Medical Devices, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Turklab Medical Devices, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Turklab Medical Devices, Inc. in the registry?
The most recently registered devices listed for Turklab Medical Devices, Inc. include RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST.