Sero-Immuno Diagnostics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Sero-Immuno Diagnostics, Inc. makes
Sero-Immuno Diagnostics, Inc. manufactures in vitro diagnostic tests for infectious disease and pregnancy detection, including a serological assay for Chagas’ disease and agglutination-based tests for beta-hCG and pregnancy confirmation.
The company’s portfolio includes Class I and Class II devices, all of which are submitted for regulatory review via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Hem Ave-Toxo Screening Hemagglutination Test Kit Ref K851976
510(k) 510(k)Dat Test For Chagas' Disease Ref K834328
510(k) 510(k)Hem Ave-Toxo Titration Hemagglutination Test Kit Ref K851977
510(k) 510(k)Dirrect Agglutination(Dag) Pregnancy Test Ref K852286
510(k) 510(k)Beta-Hcg Hemagglutination Test Ref K842181
510(k) 510(k)
Frequently asked questions
How many devices does Sero-Immuno Diagnostics, Inc. have in the registry?
The registry currently lists 5 devices for Sero-Immuno Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sero-Immuno Diagnostics, Inc.'s devices?
Among its 5 most recently registered devices, Sero-Immuno Diagnostics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Sero-Immuno Diagnostics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sero-Immuno 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 Sero-Immuno Diagnostics, Inc. in the registry?
The most recently registered devices listed for Sero-Immuno Diagnostics, Inc. include HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT, DAT TEST FOR CHAGAS' DISEASE, HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT and DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST.