21 CFR 864.3250 — Container, Specimen, Sterile
Pathology (PA) · Part 864 Subpart D—Pathology Instrumentation and Accessories · § 864.3250
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | 1 | 23 | |
| KDT | Container, Specimen Mailer And Storage, Sterile | 1 | 12 | |
| KDW | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | 1 | 4 | |
| NNI | Container, Specimen, Non-Sterile | 1 | 0 | |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | 1 | 0 | |
| NNL | Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | 1 | 0 | |
| OHZ | Urine Transport Kit (Excludes Hiv Testing) | 1 | 0 | |
| OIA | Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) | 1 | 0 | |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 1 | 0 | |
| OIE | Urine Collection Kit (Excludes Hiv Testing) | 1 | 0 |
