AOAC-RI ERP Micro June 2016

OMAMAN-29 D/ PTM Validation Report 111501 OMA ERP - June 2016 ERP Use Only

b) Catalog Number . — MDA2LIS96

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Test Kit Reagents - 3M MDA 2 - Listeria (96 tests) a) Lysis Solution (LS) tubes . – 96 (12 strips of 8 tubes) b) Listeria Reagent tubes . – 96 (12 strips of 8 tubes) c) Extra caps. – 96 (12 strips of 8 caps) d) Reagent Control (RC). – 16 (2 pouches of 8)

e) Quick Start Guide

Additional Supplies and Reagents

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a) 3M Molecular Detection System (instrument), power supply, cord, USB cable and

software

b) 3M Molecular Detection Speed Loader Tray c) 3M Molecular Detection Chill Block insert d) 3M Molecular Detection Heat Block Insert e) 3M Molecular Detection Cap/Decap Tool [Reagent] f) 3M Molecular Detection Cap/Decap Tool [Lysis]

g) Empty lysis tube rack h) Empty reagent tube rack

i) Dey-Engley (D/E) Neutralizing Broth

j) Demi Fraser Broth (with the addition of Ferric Ammonium Citrate [FAC]) k) 3M™ Hydrated Sponge Stick with 10 mL of D/E (3M Center St. Paul, MN) l) 3M™ Molecular Detection Matrix Control Kit (3M Center St. Paul, MN)

Additional media b) Oxford Agar (OX)

c)

d) Fraser Broth (FB) e) Sheep Blood Agar (SBA) g) Ottaviani Agosti Agar (OAA) h) Trypticase Soy Agar (TSA) f) PALCAM Agar

AOAC Research Institute Exp rt Review Panel Use Only

i) Trypticase Soy Agar with 0.6% Yeast Extract (TSA/YE)

j) De Man, Rogosa and Sharpe (MRS) k) Modified Oxford Agar (MOX) l) Brain Heart Infusion (BHI) broth m) Horse Blood Overlay (HBO) n) Buffered Listeria Enrichment Broth (BLEB)

Apparatus

a) Pipettes . – capable of 20µL

b) Multi-channel pipette . – capable of 20µL c) Sterile pipette tips. – capable of 20µL d) Stomacher® . – Seward or equivalent e) Filter Stomacher® bags . - Seward or equivalent f) Thermometer . – calibrated range to include 100 ± 1°C range g) Incubators . – capable of maintaining 37 ± 1°C