Wyntek Diagnostics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 12
What Wyntek Diagnostics, Inc. makes
Wyntek Diagnostics, Inc. manufactures rapid diagnostic tests for urine-based pregnancy detection, including human chorionic gonadotropin (hCG) assays, and strep A infections. Products include card-based and handheld devices for point-of-care use, such as the OSOM CARD II HCG-URINE TEST and OSOM STREP A TEST, as well as pregnancy-specific tests like the PERFECTA PREGNANCY TEST and OSOM PREGNANCY TEST.
The company’s devices are regulated under the FDA’s 510(k) pathway, with products classified as Class I (general controls) and Class II (special controls). These tests are listed in the FDA’s 510(k) database, reflecting their authorised status for urine-based diagnostic use in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Wyntek Diagnostics, Inc. have in the registry?
The registry currently lists 12 devices for Wyntek Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wyntek Diagnostics, Inc.'s devices?
Among its 12 most recently registered devices, Wyntek Diagnostics, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Wyntek Diagnostics, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Wyntek Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wyntek Diagnostics, Inc. in the registry?
The most recently registered devices listed for Wyntek Diagnostics, Inc. include OSOM CARD II HCG-URINE TEST, MODEL 102, OSOM MONO TEST 143, OSOM STREP A TEST and OSOM CARD HCG-URINE TEST.