Date: …………………………………. Company: ……………………………........ Name: ………………………………….. Signature: ………………………………….. Please complete the enclosed kit insert evaluation. Kit Insert / User Manual Evaluation 1. Intended users Remarks Does the kit insert identify intended Yes No □ □ users? 2. Identification Is the version of kit insert Yes No □ □ identifiable? 3. Applicability Does the kit insert identify the Yes No □ □ matrix(es) and target analytes that the kit is designed for, and include precautionary statements on potential interferences and other known limitations of the test if applicable? 4. Interpretation Criteria Does the kit insert explain how the Yes No □ □ test is interpreted? 5. Instructions Does the kit insert describe test Yes No □ □ sample preparations and handling or or any analyte extraction that is required? Does the kit insert include complete Yes No □ □ instructions on how to conduct the test?
Date: …………………………………. Company: ……………………………........ Name: ………………………………….. Signature: ………………………………….. Please complete the enclosed kit insert evaluation. Kit Insert / User Manual Evaluation 1. Intended users Remarks Does the kit insert identify intended users? □ Yes □ No 2. Identification Is the version of kit insert identifiable? □ Yes □ No 3. Applicability Does the kit insert identify the matrix(es) and target analytes that the kit is designed for, and include precautionary statements on potential interferences and other known limitations of the test if applicable? □ Yes □ No 4. Interpretation Criteria Does the kit insert explain how the test is interpreted? □ Yes □ No 5. Instructions Does the kit insert describe test sample preparations and handling or or any analyte extraction that is required? □ Yes □ No Does the kit insert include complete instructions on how to conduct the test? □ Yes □ No
MicroVal-Application-Form-for-ISO-16140-2-v.6-2018-1-1.docx