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System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

FDA product code NJO · 1 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.3370
Review panel
MI
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2002-10-31 – 2002-10-31

A mycolic acids analysis system is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed and pattern recognition software. The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with extraction and analysis of mycolic acids. Results should be interpreted in conjunction with other laboratory observations and procedures.

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