Inbios Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Inbios Intl., Inc. makes
Inbios Intl., Inc. manufactures in vitro diagnostic test kits, including pregnancy tests, blood glucose test strips, and immunoassays for detecting infectious diseases such as visceral leishmaniasis (Kalazar), dengue virus IgM, and West Nile virus IgM.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Insure Pregnancy Test Ref K991515
Regimes: 510(k) Registry: 510(k)Generic Blood Glucose Test Strip Ref K001092
Regimes: 510(k) Registry: 510(k)Kalazar Detect Ref K023483
Regimes: 510(k) Registry: 510(k)Denv Detect Igm Capture Elisa Ref DEN100020
Regimes: De Novo Registry: De NovoInsure Pro Test Ref K992695
Regimes: 510(k) Registry: 510(k)West Nile Detect Igm Elisa Ref K041817
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Inbios Intl., Inc. have in the registry?
The registry currently lists 6 devices for Inbios Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inbios Intl., Inc.'s devices?
Among its 6 most recently registered devices, Inbios Intl., Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Inbios Intl., Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Inbios Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Inbios Intl., Inc. in the registry?
The most recently registered devices listed for Inbios Intl., Inc. include INSURE PREGNANCY TEST, GENERIC BLOOD GLUCOSE TEST STRIP, KALAZAR DETECT and DENV DETECT IGM CAPTURE ELISA.