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ER1 Yes

Thank You for your comments and review

ER2 Yes

Thank You for your comments and review

ER3 Yes

Thank You for your comments and review

ER4 Yes

Thank You for your comments and review

ER5 Yes

Thank You for your comments and review

ER6 Yes

Thank You for your comments and review

ER1 Yes

Thank You for your comments and review

ER2 Yes

Thank You for your comments and review

ER3 Yes

Thank You for your comments and review

ER4 Yes

Thank You for your comments and review

ER5 Yes

Thank You for your comments and review

ER6 Yes

Thank You for your comments and review

ER1 Yes

Thank You for your comments and review

ER2 Yes

Thank You for your comments and review

ER3 Yes

Thank You for your comments and review

ER4 Yes

Thank You for your comments and review

ER5 Yes

Thank You for your comments and review

ER6 Yes

Thank You for your comments and review

ER1 Yes

Thank You for your comments and review

ER2 Yes

Thank You for your comments and review

ER3 Yes

Thank You for your comments and review

ER4 Yes

Thank You for your comments and review

ER5 Yes

Thank You for your comments and review

ER6 Yes

Thank You for your comments and review

ER1 Yes

Thank You for your comments and review

ER2 Yes

Thank You for your comments and review

ER3 Yes

Thank You for your comments and review

ER4 Yes

Thank You for your comments and review

ER5 Yes

Thank You for your comments and review

ER6 Yes

Thank You for your comments and review

ER1 Yes

Thank You for your comments and review

ER2 Yes

Thank You for your comments and review

ER3 Yes

Thank You for your comments and review

ER4 Yes

Thank You for your comments and review

ER5 Yes

Thank You for your comments and review

ER6 Yes

Thank You for your comments and review

General Comments about the method scope/applicability:

Is the Test Kit Method scientifically and technically sound?

Have sufficient Controls been used, including those required to calculate the rate of false-positive and

f l

l h

?

Is sufficient information included for system suitability determination and product performance or

acceptance testing?

Are the conclusions statements valid based upon data preesented?

Do you agree that the evidence or data from this and previous studies support the proposed

li bilit t t

t?

Are there sufficient data points per producct evaluated in accordance with AOAC requirements?

OMMAN-29