Azog, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Azog, Inc. makes
Azog, Inc. manufactures over-the-counter urine pregnancy test devices, including dipstick strips, cassette tests, and midstream collection kits. These products detect human chorionic gonadotropin (hCG) in urine to confirm pregnancy within minutes.
The company’s pregnancy tests are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. These devices are intended for home use and are registered with the FDA’s 510(k) database.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
Frequently asked questions
How many devices does Azog, Inc. have in the registry?
The registry currently lists 3 devices for Azog, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Azog, Inc.'s devices?
Among its 3 most recently registered devices, Azog, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Azog, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Azog, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Azog, Inc. in the registry?
The most recently registered devices listed for Azog, Inc. include AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK), AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) and AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE).