National Bio-Technical Laboratories
Country not established
- Devices
- 1
What National Bio-Technical Laboratories makes
National Bio-Technical Laboratories manufactures chemical assay standard-controls, which are reference materials used to validate and calibrate laboratory testing procedures in clinical and diagnostic settings. These products ensure accuracy and consistency in assays by providing predefined concentrations of analytes for comparison against patient samples.
The company’s portfolio is regulated under the FDA’s Class I device classification, with relevant products listed via the 510(k) premarket notification process. The manufacturer operates within the United States, adhering to applicable regulatory requirements for diagnostic and laboratory use devices.
Catalogue
Chem-Assay Standard-Controls Ref K802962
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does National Bio-Technical Laboratories have in the registry?
The registry currently lists 1 device for National Bio-Technical Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list National Bio-Technical Laboratories's devices?
Among its 1 most recently registered device, National Bio-Technical Laboratories has devices listed in FDA 510(k) (1 device).
What risk classes do National Bio-Technical Laboratories's devices fall under?
Among its 1 most recently registered device, the classes recorded for National Bio-Technical Laboratories's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from National Bio-Technical Laboratories in the registry?
The most recently registered devices listed for National Bio-Technical Laboratories include CHEM-ASSAY STANDARD-CONTROLS.