Bio Spec, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bio Spec, Inc. makes
Bio Spec, Inc. manufactures rapid diagnostic test kits for detecting respiratory infections, including kits for identifying influenza A and B viruses, as well as Group A Streptococcus (Strep A). These products use fluorescent technology to provide point-of-care results for conditions like flu and strep throat.
The company’s portfolio is regulated under FDA’s Class I device classification, with products listed via the 510(k) pathway. These devices are intended for use in the United States.
Catalogue
Bio Spec Gramafluor Test Kit Ref K860091
Regimes: 510(k) Registry: 510(k)Strep D Fluor Ref K860041
Regimes: 510(k) Registry: 510(k)Bio Spec Strep-A-Fluor Test Kit Ref K841479
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio Spec, Inc. have in the registry?
The registry currently lists 3 devices for Bio Spec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio Spec, Inc.'s devices?
Among its 3 most recently registered devices, Bio Spec, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bio Spec, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bio Spec, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bio Spec, Inc. in the registry?
The most recently registered devices listed for Bio Spec, Inc. include BIO SPEC GRAMAFLUOR TEST KIT, STREP D FLUOR and BIO SPEC STREP-A-FLUOR TEST KIT.