3M Listeria testing

FDA has determined that the following methods are scientifically valid and at least equivalent to the method of analysis in § 112.152(a) in accuracy, precision, and sensitivity[1] in detecting Listeria species and L. monocytogenes. The method of analysis in § 112.152(a) is "Testing Methodology for Listeria species or L. monocytogenes in Environmental Samples" (October 2015, Version 1).

1. AOAC Official Method 2013.10. VIDAS® UP Listeria (LPT), Listeria in select foods and environmental surfaces.
2. AOAC Official Method 2016.07. 3M Molecular Detection Assay (MDA) 2, Listeria in select foods and environmental surfaces.
3. AOAC Official Method 996.14. Assurance polyclonal enzyme immunoassay method (EIA), Listeria in select foods and environmental surfaces.
4. Chapter 10 (Listeria monocytogenes) of FDA's Bacteriological Analytical Manual (BAM, October 2017 Edition).

1 21 CFR § 112.152(b)