Analytical Luminescence Laboratory, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Analytical Luminescence Laboratory, Inc. makes
Analytical Luminescence Laboratory, Inc. manufactures urine transport tubes designed for culture and sensitivity (C & S) testing, as well as rapid bacteruria screening tests for point-of-care diagnostics.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Microstatic Urine Transport Tube For C & S Ref K851387
Regimes: 510(k) Registry: 510(k)Rapid Bacteriuria Screening Test Ref K820126
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Analytical Luminescence Laboratory, Inc. have in the registry?
The registry currently lists 2 devices for Analytical Luminescence Laboratory, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Analytical Luminescence Laboratory, Inc.'s devices?
Among its 2 most recently registered devices, Analytical Luminescence Laboratory, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Analytical Luminescence Laboratory, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Analytical Luminescence Laboratory, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Analytical Luminescence Laboratory, Inc. in the registry?
The most recently registered devices listed for Analytical Luminescence Laboratory, Inc. include MICROSTATIC URINE TRANSPORT TUBE FOR C & S and RAPID BACTERIURIA SCREENING TEST.