PQD · Blood Specimen Collection Convenience Kit (Excludes Hiv)
Clinical Chemistry · 21 CFR 862.1675 · Class 2
Overview
| Product Code | PQD |
|---|---|
| Device Name | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
