Bioware Products
Country not established
- Devices
- 4
What Bioware Products makes
Bioware Products manufactures single-use, ready-to-use diagnostic test kits for serological and immunological assays, including FTA-ABS (fluorescent treponemal antibody-absorption) and gel-based enzyme immunoassay (EIA) formats. Their products are designed for detecting antibodies in blood samples, such as those for syphilis (FTA-ABS BIOPAK) and autoimmune markers (ALK-PHOS, K/K, T/K BIOPAK variants). The kits are intended for in vitro diagnostic use in clinical laboratories.
The company’s portfolio is regulated under Class II medical devices in the US, with devices authorised via 510(k) premarket notifications to the FDA. Their products are listed in the FDA’s 510(k) database as in vitro diagnostic devices. The manufacturer is based in the United States.
Catalogue
Fta-Abs Biopak Ref K802276
Regimes: 510(k) Registry: 510(k)Alk-Phos Biopak Gel Ref K810144
Regimes: 510(k) Registry: 510(k)K/K (Asma/Ana) Universal Biopak Ref K802299
Regimes: 510(k) Registry: 510(k)T/K (Ata/Ama) Universal Biopak Ref K802308
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioware Products have in the registry?
The registry currently lists 4 devices for Bioware Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioware Products's devices?
Among its 4 most recently registered devices, Bioware Products has devices listed in FDA 510(k) (4 devices).
What risk classes do Bioware Products's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bioware Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioware Products in the registry?
The most recently registered devices listed for Bioware Products include FTA-ABS BIOPAK, ALK-PHOS BIOPAK GEL, K/K (ASMA/ANA) UNIVERSAL BIOPAK and T/K (ATA/AMA) UNIVERSAL BIOPAK.