AOAC-RI ERP Book MICRO.pdf

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2. There should be an applicability statement,

specific to AOAC, In the package insert.

Per AOAC website:

http://www.aoac.org/imis15_prod/AOAC_Do

cs/SPDS/Formats_AOAC_collab.pdf In the

Package Insert the applicability statement is

prior to the table. In AOAC PTM studies, the

3M Molecular Detection Assay 2 – Listeria

was found to be an effective method for the

detection of Listeria species. The matrices

tested in the study are shown in Table 3. The

limit of detection of the 3M Molecular

Detection Assay 2 – Listeria method is 1-5

colony forming units per validated test

portion size (in Table 3).

3. There should be an apparatus/media section

that details all of the equipment needed to

perform the test that is not supplied by 3 in the

package insert.

The Package insert lists ALL compenents that

come with the kit.

ER5 Yes

ER6 Yes

ER1 Yes

Thank You for your comments and review

ER2 Yes

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ER3 Yes

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ER4 Yes

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ER5 Yes

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ER6 Yes

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ER1 Yes

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ER2 Yes

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ER3 Yes

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ER4 Yes

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ER5 Yes

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ER6 Yes

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ER1 NO

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ER2 NO

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ER3 NO

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ER4 NO

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ER5 NO

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ER6 NO

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Are the figures and tables sufficiently explanatory without the need to refer to the text?

Are all the figures and tables pertinent?

Could some be omitted and covered by a simple statement?

OMMAN-29