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e-CFR data is current as of September 24, 2020

Title 21Chapter ISubchapter HPart 864Subpart C → §864.2280


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart C—Cell And Tissue Culture Products


§864.2280   Cultured animal and human cells.

(a) Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

(b) Classification. Class I (general 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 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

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