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FDA cleared for In Vitro Diagnostic (IVD) use in the United States. This item does not have CE approval.
|Analyte / Target||Phenylalanine|
|Base Catalog Number||575300|
|Diagnostic Solutions||Newborn Screening|
|Sample Type||Dried Blood Spot|
|Sample Volume||2 x 3.2 mm (1/8”) or 4.7 mm (3/16”) dried blood spot|5 uL Whole Blood|
|Usage Statement||FDA cleared for In Vitro Diagnostic (IVD) use in the United States. This item does not have CE approval.|