Lab Ability, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Lab Ability, Inc. makes
Lab Ability, Inc. manufactures diagnostic reagents and tools for microbiological testing, including serological assays like the SHIGELLA SERA-CHEK, reagent standards (Q-CHECK REAGENT STANDARDS), and bacterial culture loops (Q-CHECK CULTI-LOOPS). The company also produces antibiotic susceptibility test discs, such as the SELECTO-DISC NOVOBIOCIN 5UG and general SELECTRO-DISC variants, used in clinical microbiology labs.
These products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I and Class II. The company’s offerings are listed in the FDA’s 510(k) registry. Lab Ability, Inc. is based in the United States.
Catalogue
Shigella Sera-Chek Ref K813191
Regimes: 510(k) Registry: 510(k)Q-Check Reagent Standards Ref K830134
Regimes: 510(k) Registry: 510(k)Q-Check Culti-Loops Ref K830133
Regimes: 510(k) Registry: 510(k)Selecto-Disc Novobiocin 5UG Ref K833407
Regimes: 510(k) Registry: 510(k)Selectro-Disc Ref K832436
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lab Ability, Inc. have in the registry?
The registry currently lists 5 devices for Lab Ability, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lab Ability, Inc.'s devices?
Among its 5 most recently registered devices, Lab Ability, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Lab Ability, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Lab Ability, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lab Ability, Inc. in the registry?
The most recently registered devices listed for Lab Ability, Inc. include SHIGELLA SERA-CHEK, Q-CHECK REAGENT STANDARDS, Q-CHECK CULTI-LOOPS and SELECTO-DISC NOVOBIOCIN 5UG.