Stellar Bio Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Stellar Bio Systems, Inc. makes
Stellar Bio Systems, Inc. manufactures indirect fluorescence assay (IFA) test systems for detecting specific antibodies and viral antigens, including anti-native DNA IgG, Epstein-Barr virus (EBV) IgG, Chlamydia trachomatis IgG, herpes simplex virus 1, anti-nuclear antibodies (ANA) IgG, and human cytomegalovirus (HCMV). These tests are designed for serological analysis in clinical diagnostics, supporting the identification of immune responses to infections and autoimmune markers.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with submissions recorded in the FDA’s 510(k) registry. Products are intended for use in the United States, where regulatory compliance is governed by the FDA’s medical device authorization framework.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ifa For Chlamydia Trachomatis Igg Antibody Ref K914953
Regimes: 510(k) Registry: 510(k)Indirect Fluorescent Assay For Herpes Simplex 1 Ref K905608
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Indirect Fluorescent Assay For (Hcmv) Ref K882835
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stellar Bio Systems, Inc. have in the registry?
The registry currently lists 7 devices for Stellar Bio Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stellar Bio Systems, Inc.'s devices?
Among its 7 most recently registered devices, Stellar Bio Systems, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Stellar Bio Systems, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Stellar Bio 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 Stellar Bio Systems, Inc. in the registry?
The most recently registered devices listed for Stellar Bio Systems, Inc. include INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY, EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM, IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY and INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1.