N6264517Q0024_Amendment0001.pdf

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Opiates Reagent Kits
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N6264517Q0024
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Amendment 0001

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N6264517Q0024

N6264517Q0024 Amendment 0001 16 August 2017

Description of Amendment/Modification:

The purpose of this amendment is to answer questions received regarding the solicitation. The hour and date specified for receipt of offer is not extended. There are no other changes.

The following have been added by full text:

AMENDMENT 0001

Question 1: Which reagent do you currently use?

Answer 1: Emit II Plus Opiate Assay

Question 2: Which calibrator do you use? (codeine, morphine, hydrocodone or hydromorphone) Answer 2: morphine

Question 3: What is the cross reactivity level for the other analytes listed above to your calibrator ?

Answer 3: Per the package insert, with 300 ng/mL morphine calibration:

Codeine – 102-306 ng/mL Hydrocodone – 247 ng/mL Hydromorphone – 498 ng/mL

All non-negative screening results go through a second test consisting of the same Emit II Plus Opiate Assay calibrated with morphine at 2000 ng/mL for the purpose of detecting codeine and morphine at the Department of Defense 2000 ng/mL cutoff. Codeine – 660 – 1980 ng/mL.

(End of Summary of Changes)

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