21 CFR 866.2900 — System, Transport, Aerobic
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2900
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JTW | System, Transport, Aerobic | 1 | 43 | 3rd Party |
| JTX | Transport Systems, Anaerobic | 1 | 8 | 3rd Party |
| LIO | Device, Specimen Collection | 1 | 63 | 3rd Party |
| LKS | Device, Parasite Concentration | 1 | 13 | |
| OID | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | 1 | 0 |
