Toxi-Lab, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Toxi-Lab, Inc. makes
Toxi-Lab, Inc. manufactures single-use chemical extraction cartridges and rapid diagnostic test systems for detecting drugs of abuse, including opiates, and measuring alcohol levels in urine or oral fluid samples. Their products are designed for on-site testing, such as in law enforcement, medical settings, and workplace drug screening.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in the United States.
Catalogue
Spec(Tm) Extraction Cartridge Ref K901694
Regimes: 510(k) Registry: 510(k)Toxi*lab Ltd Opiate System Ref K932209
Regimes: 510(k) Registry: 510(k)On*site Alcohol Ref K923337
Regimes: 510(k) Registry: 510(k)On-Site Alcohol Ref K903223
Regimes: 510(k) Registry: 510(k)Alpha Urine Sample Ref K900626
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Toxi-Lab, Inc. have in the registry?
The registry currently lists 5 devices for Toxi-Lab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Toxi-Lab, Inc.'s devices?
Among its 5 most recently registered devices, Toxi-Lab, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Toxi-Lab, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Toxi-Lab, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Toxi-Lab, Inc. in the registry?
The most recently registered devices listed for Toxi-Lab, Inc. include SPEC(TM) EXTRACTION CARTRIDGE, TOXI*LAB LTD OPIATE SYSTEM, ON*SITE ALCOHOL and ON-SITE ALCOHOL.