21 C.F.R. § 866.2900

Microbiological specimen collection and transport device

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(a) Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

(b) Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020]

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). “” 21 C.F.R. § 866.2900 . An amniotic fluid sampler, which includes specimen containers as components, is a class II device.”

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