Osmotic fragility test.

21 C.F.R. § 864.6600
in effectEffective: 2024-07-01
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(a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (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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