Thromboplastin generation test.

21 C.F.R. § 864.7900
in effectEffective: 2024-07-01
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(a) Identification. A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

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