Disease Detection International, Inc.
United StatesFDA applicant, unverified
- Devices
- 20
What Disease Detection International, Inc. makes
Disease Detection International, Inc. manufactures rapid diagnostic test kits for detecting antibodies and antigens in blood or serum samples. These include lateral-flow immunoassays for human chorionic gonadotropin (HCG) to confirm pregnancy, as well as serological tests for infectious diseases such as toxoplasmosis, cytomegalovirus (CMV), rubella, herpes, and streptococcal infections. The company also produces home pregnancy test devices for visual results.
The company’s products are regulated under the FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway. These tests are listed in the FDA’s 510(k) database, reflecting their authorised status for in vitro diagnostic use in the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Disease Detection International, Inc. have in the registry?
The registry currently lists 20 devices for Disease Detection International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Disease Detection International, Inc.'s devices?
Among its 20 most recently registered devices, Disease Detection International, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Disease Detection International, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Disease Detection International, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Disease Detection International, Inc. in the registry?
The most recently registered devices listed for Disease Detection International, Inc. include IMMUNOCARD(TM) HCG II TEST KIT, MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT, IMMUNOCARD HCG II-S TEST KIT and MODIFIED DDI SEROCARD CMV IGG TEST KIT.