Advanced Biological Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Advanced Biological Products, Inc. makes
Advanced Biological Products, Inc. manufactures enzyme-linked immunosorbent assay (ELISA) kits for detecting specific antibodies, including those for double-stranded DNA (DOXA), Smith antigen (SM), and other autoimmune markers such as SCL-70 and ribonucleoprotein (RNP). Their portfolio includes standalone and combination test formats for clinical diagnostics, such as the ELISA-DOXA SSB, ELISA-DOXA COMBI-4, and ELISA-DPXA SSA kits.
These diagnostic devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance requirements. The manufacturer operates from the United States.
Catalogue
Elisa-Doxa Ssb Ref K924946
Regimes: 510(k) Registry: 510(k)Elisa-Doxa Sm Ref K924947
Regimes: 510(k) Registry: 510(k)Elisa-Doxa Combi-4 Ref K924951
Regimes: 510(k) Registry: 510(k)Elisa-Doxa Jo-1 Ref K924950
Regimes: 510(k) Registry: 510(k)Elisa-Dpxa Ssa Kit Ref K924945
Regimes: 510(k) Registry: 510(k)Elisa-Doxa Scl-70 Ref K924949
Regimes: 510(k) Registry: 510(k)Elisa-Doxa Combi-6 Ref K924952
Regimes: 510(k) Registry: 510(k)Elisa-Doxa Sm/Rnp Ref K924948
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Biological Products, Inc. have in the registry?
The registry currently lists 8 devices for Advanced Biological Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Biological Products, Inc.'s devices?
Among its 8 most recently registered devices, Advanced Biological Products, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Advanced Biological Products, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Advanced Biological Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Biological Products, Inc. in the registry?
The most recently registered devices listed for Advanced Biological Products, Inc. include ELISA-DOXA SSB, ELISA-DOXA SM, ELISA-DOXA COMBI-4 and ELISA-DOXA JO-1.