21 C.F.R. § 864.7875   Thrombin time test.

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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§ 864.7875   Thrombin time test.

(a) Identification. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

(b) Classification. Class II (performance standards).

[45 FR 60628, Sept. 12, 1980]

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