Title 21

SECTION 864.9600

864.9600 Potentiating media for in vitro diagnostic use.

§ 864.9600 Potentiating media for in vitro diagnostic use.

(a) Identification. Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]

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