What are some examples of entities that FDA considers to be ASRs?
• a single antibody (e.g., an anti-troponin I polyclonal or monoclonal antibody, whether untagged or tagged, e.g., conjugated to horseradish peroxidase), • a single forward/reverse oligonucleotide primer pair1 (e.g., a primer pair for amplification of a single amplicon, such as for amplification of the ΔF508 locus of the gene encoding the cystic fibrosis transmembrane regulator (CFTR)), or single forward or reverse primer individually, • a nucleic acid probe2 (whether untagged or tagged, e.g., conjugated to biotin or Cy™3) intended to bind a single complementary amplified or unamplified nucleic acid sequence, • a single purified protein or peptide (e.g., purified B-type natriuretic peptide).
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- What are some examples of entities that FDA considers to be ASRs?
