Potentiating media for in vitro diagnostic use.

21 C.F.R. § 864.9600
in effectEffective: 2024-07-01
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(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.

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21 C.F.R. § 864.9600 — Potentiating media for in vitro diagnostic use | Code of Federal Regulations | Corpus