Labone, Inc.
United StatesFDA applicant, unverified FDA FEI 1930987
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Labone, Inc. makes
Labone, Inc. manufactures enzyme immunoassay (EIA) micro-plate tests for detecting cocaine metabolites and cotinine, used primarily in clinical and forensic settings to measure drug exposure and nicotine presence in biological samples.
These products are regulated as Class II medical devices in the US and are listed under the FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Labone Cocaine Metabolite Micro-Plate Eia Ref K040198
Regimes: 510(k) Registry: 510(k)Labone Micro-Plate Cotinine Eia Ref K033601
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1930987
- Address
- 10101 Renner Blvd, LENEXA, KS, 66219
Frequently asked questions
How many devices does Labone, Inc. have in the registry?
The registry currently lists 2 devices for Labone, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Labone, Inc.'s devices?
Among its 2 most recently registered devices, Labone, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Labone, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Labone, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Labone, Inc. in the registry?
The most recently registered devices listed for Labone, Inc. include LABONE COCAINE METABOLITE MICRO-PLATE EIA and LABONE MICRO-PLATE COTININE EIA.