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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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Subpart H - Hematology Kits and Packages |
§ 864.7040 - Adenosine triphosphate release assay.
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§ 864.7040 Adenosine triphosphate release assay.
(a) Identification. An adenosine triphosphate release assay is a device that measures the release of adenosine triphosphate (ATP) from platelets following aggregation. This measurement is made on platelet-rich plasma using a photometer and a luminescent firefly extract. Simultaneous measurements of platelet aggregation and ATP release are used to evaluate platelet function disorders.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60609, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]