21 C.F.R. § 864.7040   Adenosine triphosphate release assay.

Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages

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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).

[45 FR 60609, Sept. 12, 1980]

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