Biostar Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Biostar Medical Products, Inc. makes
Biostar Medical Products, Inc. manufactures diagnostic assay kits for detecting and quantifying specific antibodies, including IgG and IgM anti-dsDNA, rheumatoid factor (RF), and immune complexes. Their products include semi-quantitative and quantitative assays designed for laboratory use in autoimmune disease testing.
These 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) registry. Biostar Medical Products, Inc. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Biostar* Reads* Immune Complex Assay Kit Ref K861499
Regimes: 510(k) Registry: 510(k)Semi-Quantitative Assay For Det. Of Igg And Igm Ref K893897
Regimes: 510(k) Registry: 510(k)Reads Rf Test Kit For Igm Rheumatoid Factor Ref K863238
Regimes: 510(k) Registry: 510(k)Biostar Re-A-Ds Immune Complex Assay Kit Ref K853697
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biostar Medical Products, Inc. have in the registry?
The registry currently lists 5 devices for Biostar Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biostar Medical Products, Inc.'s devices?
Among its 5 most recently registered devices, Biostar Medical Products, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Biostar Medical Products, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Biostar Medical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biostar Medical Products, Inc. in the registry?
The most recently registered devices listed for Biostar Medical Products, Inc. include QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA, BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT, SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM and READS RF TEST KIT FOR IGM RHEUMATOID FACTOR.