21 CFR 862.1675 — Tubes, Vacuum Sample, With Anticoagulant
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1675
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 2 | 39 | |
| GJE | Tray, Blood Collection | 2 | 7 | 3rd Party |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 236 | |
| OYJ | Dna Specimen Collection, Saliva | 2 | 7 | |
| PJC | Newborn Screening Specimen Collection Paper | 2 | 2 | |
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | 2 | 9 | |
| PJE | Blood/Plasma Collection Device For Dna Testing | 2 | 8 | |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | 0 | |
| PRJ | Capillary Blood Collection Device For Alternative Site Collection | 2 | 2 | |
| QZG | Menstrual Blood Collection Device | 2 | 0 |
