Intercare Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Intercare Diagnostics, Inc. makes
Intercare Diagnostics, Inc. manufactures diagnostic tests for tick-borne diseases, including rapid immunochromatographic assays for detecting tick-borne pathogens, and enzyme immunoassays for chlamydia confirmation in tissue samples. The company also produces hematology control mixtures for quality assurance in laboratory settings and a biofeedback interface system for medical monitoring applications.
The portfolio includes Class I and Class II devices, with regulatory submissions filed under the FDA’s 510(k) pathway. Products are listed in the U.S. regulatory database, and the company is headquartered in the United States.
Catalogue
Indx Dip S Ticks Ref K901597
Regimes: 510(k) Registry: 510(k)Chlamydia Tissue Culture Confirmation Test (Eia) Ref K862948
Regimes: 510(k) Registry: 510(k)Indxtm Dip-S-Tickstm Ref K920569
Regimes: 510(k) Registry: 510(k)The Mirage System Biofeedback Interface Ref K941938
Regimes: 510(k) Registry: 510(k)Hematology Control Mixtures For Quality Control Ref K893895
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intercare Diagnostics, Inc. have in the registry?
The registry currently lists 5 devices for Intercare Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intercare Diagnostics, Inc.'s devices?
Among its 5 most recently registered devices, Intercare Diagnostics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Intercare Diagnostics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Intercare 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 Intercare Diagnostics, Inc. in the registry?
The most recently registered devices listed for Intercare Diagnostics, Inc. include INDX DIP S TICKS, CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA), INDXTM DIP-S-TICKSTM and THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE.