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24

Lysis Solution (LS)

tubes

Pink solution

in clear tubes

96 (12 strips of 8 tubes) 580

µ

L of LS per tube

Racked and

ready to use

Listeria

Reagent tubes Blue tubes

96 (12 strips of 8 tubes)

Lyophilized specific

amplification and

detection mix

Ready to use

Extra caps

Blue caps

96 (12 strips of 8 caps)

Ready to use

Reagent Control (RC)

Clear flip-top

tubes

16 (2 pouches of 8

individual tubes)

Lyophilized control

DNA, amplification

and detection mix

Ready to use

Quick Start Guide

1

1

The Negative Control, not provided in the kit, is sterile enrichment medium, e.g., Demi-Fraser

2

Broth. Do not use water as a Negative Control.

3

4

SAFETY

5

The user should read, understand and follow all safety information in the instructions for the 3M

6

Molecular Detection System and the 3M Molecular Detection Assay 2 -

Listeria.

Retain the

7

safety instructions for future reference.

8

9

WARNING:

Indicates a hazardous situation, which, if not avoided, could result

in death or serious injury and/or property damage.

CAUTION:

Indicates a hazardous situation, which, if not avoided, could result

in minor or moderate injury and/or property damage.

NOTICE:

Indicates a potentially hazardous situation which, if not avoided,

could result in property damage.

10

WARNING

Do not use the 3M Molecular Detection Assay 2

- Listeria

in the diagnosis of conditions in

11

humans or animals.

12

13

The 3M Molecular Detection Assay 2 -

Listeria

method may generate

Listeria monocytogenes

to

14

levels sufficient to cause stillbirths and fatalities in pregnant women and the immuno

15

compromised, if exposed.

16

AOAC Research Institute

Expert Review Panel Use Only

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol

OMA ERP - June 2016

ERP Use Only