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The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

PerkinElmer 226 Sample Collection Device is designed to provide a uniform surface for the collection of blood spots. A drop of blood is applied to the filter paper and allowed to soak through the paper. The sample is then air dried and sent to a laboratory for further analysis. The PerkinElmer 226 Sample Collection contains Ahlstrom 226 filter paper that is made from 100% pure cotton linters with no wet-strength additives added and conforms to the Recognized Standard CLSI LA4-A4. The Ahlstrom 226 filter paper has four performance characteristics that can be assessed with lysed or intact red blood cells; blood absorption time, blood spot diameter, serum absorption volume and homogeneity. Physical properties of the Ahlstrom 226 filter paper monitored during manufacturing are basis weight, pH and ash content. Basis weight should be 110 lb ± 5% per ream (179 g/m2 ± 5%). A ream is defined as 500 sheets 24" x 36" (ASTM D646-96). The pH should be 5.7 to 7.5 (Test method ISO 6599:1981). Ash percent limit is a maximum of 0.1% (Test method A of ASTM D586-97a). Ahlstrom (manufacturer of paper) name and lot number appears on the PerkinElmer 226 Sample Collection Device along with a PerkinElmer specific lot identifier.

for the indications for use stated in the enclosure

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