21 CFR 862.2050 — Mixer, Blood Tube
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2050
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification Rationale
Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also 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 |
|---|---|---|---|---|
| GLE | Mixer, Blood Tube | 1 | 5 | |
| JBS | Timer, General Laboratory | 1 | 0 | |
| JJP | Electrode, Ion Selective (Non-Specified) | 1 | 3 | |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | 38 | |
| JQO | Balance, Analytical | 1 | 0 | |
| JQQ | Dialyzer | 1 | 1 | |
| JQY | Ph Meter | 1 | 8 | |
| JQZ | Polarimeter | 1 | 1 | |
| JRB | Micro Mixer | 1 | 0 | |
| JRC | Micro Pipette | 1 | 6 | |
| JRG | Block, Heating | 1 | 3 | |
| JRI | Cuvette, Thermostated | 1 | 4 | |
| JRJ | Unit, Drying | 1 | 1 | |
| JRK | Evaporator | 1 | 0 | |
| JRL | Unit, Filter, Membrane | 1 | 9 | |
| JRM | Freezer | 1 | 7 | |
| JRO | Blender/Mixer | 1 | 0 | |
| JRQ | Shaker/Stirrer | 1 | 8 | |
| JRR | Regulator, Temperature | 1 | 4 | |
| JRS | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | 1 | 0 | |
| LCI | Automated Radioimmunoassay Systems, For Clinical Use | 1 | 3 | 3rd Party |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | 3 | |
| QBV | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | 1 | 2 | 3rd Party |
