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Enzymatic amplification of beta-globin genomic sequences and restriction site analysis for diagnosis of sickle cell anemia. Science. 1985", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:52:49Z", null, 0, 0, "09000064b909ad54"], ["FDA-2025-N-4622-0028", "FDA", "FDA-2025-N-4622", "Reference 26 - McCombie WR, McPherson JD, Mardis ER. Next-Generation Sequencing Technologies. 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Amplification of nucleic acids by polymerase chain reaction (PCR) and other methods and their applications. Crit Rev Biochem Mol Biol. 1991", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:52:53Z", null, 0, 0, "09000064b909ad56"], ["FDA-2025-N-4622-0003", "FDA", "FDA-2025-N-4622", "Reference 1 - In Vitro Companion Diagnostic Devices \u2013 Guidance for Industry and Food and Drug Administration Staff", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:50:45Z", null, 0, 0, "09000064b9099bec"], ["FDA-2025-N-4622-0015", "FDA", "FDA-2025-N-4622", "Reference 13 - P150044 Summary of Safety and Effectiveness", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:51:45Z", null, 0, 0, "09000064b909acb2"], ["FDA-2025-N-4622-0017", "FDA", "FDA-2025-N-4622", "Reference 15 - P160038 Summary of Safety and Effectiveness", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:52:01Z", null, 0, 0, "09000064b909ad36"], ["FDA-2025-N-4622-0005", "FDA", "FDA-2025-N-4622", "Reference 3 - P140020 Summary of Safety and Effectiveness", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:50:56Z", null, 0, 0, "09000064b909a087"], ["FDA-2025-N-4622-0012", "FDA", "FDA-2025-N-4622", "Reference 10 - P120019 Summary of Safety and Effectiveness", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:51:32Z", null, 0, 0, "09000064b909acae"], ["FDA-2025-N-4622-0004", "FDA", "FDA-2025-N-4622", "Reference 2 - P110020 Summary of Safety and Effectiveness", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:50:48Z", null, 0, 0, "09000064b909a086"], ["FDA-2025-N-4622-0018", "FDA", "FDA-2025-N-4622", "Reference 16 - P160040 Summary of Safety and Effectiveness", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:52:04Z", null, 0, 0, "09000064b909ad37"], ["FDA-2025-N-4622-0027", "FDA", "FDA-2025-N-4622", "Reference 25 - Saiki RK, Gelfand DH, Stoffel S, et al. Primer-directed enzymatic amplification of DNA with a thermostable DNA polymerase. Science. 1988", "Supporting & Related Material", "Background Material", "2025-11-25T05:00:00Z", 2025, 11, null, null, "2025-11-25T19:52:57Z", null, 0, 0, "09000064b909ad57"], ["FDA-2025-N-4622-0024", "FDA", "FDA-2025-N-4622", "Reference 22 - Curtin, SC, Tejada-Vera, B, Bastian, Deaths: Leading Causes for 2021. 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