Does the kit insert describe the use of Yes No □ □ any internal or external quality control features? Does the kit insert state which part of Yes No □ □ the method is MicroVal certified? 6. Shelf Life Does the labelling include Yes No □ □ information about the shelf life and storage conditions for the kit? 7. Detection Limit /Limit of Quantitation If applicable, does the kit insert Yes No □ □ include the limits of detection and/or quantitation. Do the claimed LOQ / LOD agree with Yes No □ □ supporting data? 8. Technical Assistance Does the kit insert provide Yes No □ □ information (Website, email, telephone and FAX numbers) where users can obtain technical assistance?
Does the kit insert describe the use of any internal or external quality control features? □ Yes □ No Does the kit insert state which part of the method is MicroVal certified? □ Yes □ No 6. Shelf Life Does the labelling include information about the shelf life and storage conditions for the kit? □ Yes □ No 7. Detection Limit /Limit of Quantitation If applicable, does the kit insert include the limits of detection and/or quantitation. □ Yes □ No Do the claimed LOQ / LOD agree with supporting data? □ Yes □ No 8. Technical Assistance Does the kit insert provide information (Website, email, telephone and FAX numbers) where users can obtain technical assistance? □ Yes □ No
MicroVal-Application-Form-for-ISO-16140-2-v.6-2018-1-1.docx