Attachment 1 Questions & Answers.pdf

Attachment 1 – Questions & Answers Amendment CSS-FDA-1222425_0001

Pipette Calibration Services

1. At least 2 readings @ low and High Volume. Does that mean 2 sample readings taking for the nominal and 2 readings at the low end?

Answer: Yes, low end and high end for each pipette based on the maximum volume of the pipette.

2. In this same document. There is no mention of As found data and As left Data for the reports.

Do you just need As left data only?

Answer: If a pipette is found to be out of calibration during the initial procedure, we would expect to be notified so we can take appropriate actions. Although an As Found and As Left would be preferable, and based on previous sentence, As left would be minimally acceptable.

3. For the multi-channels. Do you need 2 readings at low and high for each channel?

Answer: Yes

4. In the write-up it states Bi-Annual Pipette Calibration are required for over 180 pipettes. On

#12, it states 4 (12 Channel), 16 (8 Channel), and 452 single channel (equals Qty of 472).

Does the Qty 472 reference in both March and September, there will be 472 pipettes to calibrate, or, the Qty 472 is for the full year, meaning half in March and the other half in September?

Answer: Number 12 states, “The estimates represent a one-year period of performance”.

Therefore, the quantities for a., b., and c. are estimated totals for an entire year. *Meaning with the required biannual calibrations the estimated totals are 12a., b., and c.