Synbiotics Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Synbiotics Corp. makes
Synbiotics Corp. manufactures rapid diagnostic test kits for infectious disease detection, including a human chorionic gonadotropin (hCG) test for pregnancy confirmation, a streptococcal A antigen test, and a direct immunofluorescence test kit for *Chlamydia trachomatis* detection.
These products are regulated under FDA 510(k) clearance as Class I and Class II medical devices and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Rapidtest-Hcg (Tm) Ref K883235
510(k) 510(k)Nova Strep A Ref K873784
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Synbiotics Corp. have in the registry?
The registry currently lists 3 devices for Synbiotics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Synbiotics Corp.'s devices?
Among its 3 most recently registered devices, Synbiotics Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Synbiotics Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Synbiotics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Synbiotics Corp. in the registry?
The most recently registered devices listed for Synbiotics Corp. include RAPIDTEST-HCG (TM), NOVA STREP A and MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT.