Embryotech Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Embryotech Laboratories, Inc. makes
Embryotech Laboratories, Inc. manufactures home diagnostic test kits designed to screen for male infertility, including the FERTILMARQ Home Diagnostic Screening Test Kit and the FERTILMARQ Test Kit. These products are intended for use in assessing sperm concentration and motility in a home setting, providing preliminary fertility assessment results.
The company’s products fall under FDA Class II medical devices and are listed via the 510(k) pathway. These devices are regulated under US jurisdiction, where Embryotech Laboratories, Inc. is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Fertilmarq Test Kit Ref K983473
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Embryotech Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Embryotech Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Embryotech Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Embryotech Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Embryotech Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Embryotech Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Embryotech Laboratories, Inc. in the registry?
The most recently registered devices listed for Embryotech Laboratories, Inc. include FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY and FERTILMARQ TEST KIT.