Bion Ent., Ltd.
Country not established
- Devices
- 14
What Bion Ent., Ltd. makes
Bion Ent., Ltd. manufactures diagnostic test systems for detecting viral and bacterial antigens, including slides for Borrelia burgdorferi, respiratory syncytial virus, mumps, Epstein-Barr virus, cytomegalovirus (CMV), herpes simplex virus (HSV-1/HSV-2), varicella-zoster virus, and Chlamydia trachomatis (LGV-1). The portfolio also includes antibody test kits for mumps, Epstein-Barr virus (VCA), and antinuclear antibodies (ANA), alongside direct identification control slides for laboratory use.
The company’s diagnostic products are classified under FDA’s Class I and Class II categories, with submissions recorded in the FDA’s 510(k) registry. These devices are intended for in vitro diagnostic use and are listed under U.S. regulatory authorities.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Bion Ent., Ltd. have in the registry?
The registry currently lists 14 devices for Bion Ent., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bion Ent., Ltd.'s devices?
Among its 14 most recently registered devices, Bion Ent., Ltd. has devices listed in FDA 510(k) (14 devices).
What risk classes do Bion Ent., Ltd.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Bion Ent., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bion Ent., Ltd. in the registry?
The most recently registered devices listed for Bion Ent., Ltd. include BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE, RESPIRATORY SYNCYTIAL VIRUS, BION MUMPS-G ANTIBODY TEST SYSTEM and BION DIRECT IDENTIFICATION CONTROL SLIDE.