Inactive

See amendment 1 to the combined synopsis/solicitation attached. Questions/Answers: 1. Page 1 section “Background” refers to “sorting the cells”. Is it possible to clarify if this mean they want a “cel... See amendment 1 to the combined synopsis/solicitation attached. Questions/Answers: 1. Page 1 section “Background” refers to “sorting the cells”. Is it possible to clarify if this mean they want a “cell sorter” or will the cells be pre-sorted prior to being taken to this new instrument? We simply want to clarify the requirement to ensure we do not quote the wrong item. Response: Please see amendment 1 for changes that should address the question. 2. Page 1 section “Technical Requirements” lists requirement of In-Vitro Diagnostic testing. Are you able to clarify if the instrument is going to be used for research purposes only? Is performing these tests under the Laboratory Developed Testing umbrella sufficient? Response: Please see amendment 1 for changes that should clarify the question. 3. Page 1 section “Technical Requirements” lists “Software must be compatible with existing CBER Center cytometers for ease and accuracy of assay replication.” Does this mean it must be the same manufacturer or just the data that needs to be compatible? Response: Please see amendment 1 for changes that should clarify the question. 4. Page 2 section “Technical Requirements” list “Shall have at least three color basic In-Vitro Diagnostic (IVD)” Can you please expand on what is needed to meet this requirement? Instruments aren’t IVD cleared in flow, but some assays are. Does this mean it needs to be capable of having an IVD cleared assay assigned to the instrument? Or is having these tests done by Laboratory Developed Tests acceptable? Response: Please see amendment 1 for changes that should address the question.