§864.9600. Potentiating media for in vitro diagnostic use.
21 C.F.R. § 864.9600
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.
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.
Notes, amendments, and revision history
Amendments
[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]