Lee Laboratories, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1025402
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
What Lee Laboratories, Inc. makes
Lee Laboratories, Inc. manufactures rapid diagnostic tests under the VISTA ANTIGEN brand, designed to detect specific bacterial antigens associated with brucellosis and salmonellosis in clinical samples. These include tests for *Brucella abortus*, *Brucella melitensis*, and various serotypes and O groups of *Salmonella* (H and O antigens). The tests are intended for use in veterinary and human diagnostic settings to identify infectious pathogens.
The company’s diagnostic tests fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance via the FDA. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution. The manufacturer is based in the United States.
Catalogue
Vista Antigen Brucella Abortus Ref K972394
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella H A Ref K972392
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella H D Ref K972389
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella H C Ref K972390
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella O Group B Ref K972386
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella O Group A Ref K972387
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella H B Ref K972391
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella O Group D Ref K972395
Regimes: 510(k) Registry: 510(k)Vista Antigen Brucella Melitensis Ref K972396
Regimes: 510(k) Registry: 510(k)Vista Antigen Salmonella O Group C Ref K972388
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1025402
- Address
- 1475 ATHENS HWY., GRAYSON, GA, 30017
Frequently asked questions
How many devices does LEE LABORATORIES, INC. have in the registry?
The registry currently lists 10 devices for LEE LABORATORIES, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list LEE LABORATORIES, INC.'s devices?
Among its 10 most recently registered devices, LEE LABORATORIES, INC. has devices listed in FDA 510(k) (10 devices).
What risk classes do LEE LABORATORIES, INC.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for LEE LABORATORIES, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from LEE LABORATORIES, INC. in the registry?
The most recently registered devices listed for LEE LABORATORIES, INC. include VISTA ANTIGEN BRUCELLA ABORTUS, VISTA ANTIGEN SALMONELLA H A, VISTA ANTIGEN SALMONELLA H D and VISTA ANTIGEN SALMONELLA H C.