21 C.F.R. § 864.3250

Specimen transport and storage container

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(a) Identification. A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[54 FR 47206, Nov. 13, 1989, as amended at 65 FR 2310, Jan. 14, 2000; 65 FR 18234, Apr. 7, 2000; 90 FR 55981, Dec. 4, 2025]

Notes of Decisions

Cited in 1 case, 1994–1994 · leading case: United States v. An Undetermined No. of Unlabeled Cases, Etc., Clinical Reference Lab'y, Inc., Claimant-Appellant, 21 F.3d 1026 (10th Cir. 1994).

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United States v. An Undetermined No. of Unlabeled Cases, Etc., Clinical Reference Lab'y, Inc., Claimant-Appellant, 21 F.3d 1026 (10th Cir. 1994). · cites it 2× “21 C.F.R. § 864.3250 . The regulations place into class I a related item, a “microbiological specimen collection and transport device,” used to aid in the diagnosis of disease caused by pathogenic microorganisms and defined- as “a specimen collecting chamber intended for medical…”

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