Self Care Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Self Care Systems, Inc. makes
Self Care Systems, Inc. manufactures rapid diagnostic test kits for at-home use, including a 5-minute color-based test for strep-A infections, a modified version for detecting occult blood in stool, and urine blood test sticks.
These products are regulated as Class I and Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Ez Detect, 5 Minute Strep-A Color Test Ref K860923
Regimes: 510(k) Registry: 510(k)Modified Ez Detect Occult Blood Test In Stool Ref K860028
Regimes: 510(k) Registry: 510(k)Ez Detech-Urine Blood Test Sticks Ref K854358
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Self Care Systems, Inc. have in the registry?
The registry currently lists 3 devices for Self Care Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Self Care Systems, Inc.'s devices?
Among its 3 most recently registered devices, Self Care Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Self Care Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Self Care Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Self Care Systems, Inc. in the registry?
The most recently registered devices listed for Self Care Systems, Inc. include EZ DETECT, 5 MINUTE STREP-A COLOR TEST, MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL and EZ DETECH-URINE BLOOD TEST STICKS.