21 CFR 862.1145 — Titrimetric Permanganate And Bromophenol Blue, Calcium
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1145
Identification
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CHC | Titrimetric Permanganate And Bromophenol Blue, Calcium | 2 | 0 | 3rd Party |
| CHW | Titrimetric With Edta And Indicator, Calcium | 2 | 3 | 3rd Party |
| CHZ | Di (O-Hydroxyphenylimine) Ethane, Calcium | 2 | 1 | 3rd Party |
| CIA | Methylthymol Blue, Calcium | 2 | 5 | 3rd Party |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 99 | 3rd Party |
| CID | Alizarin Sulfonate, Calcium | 2 | 2 | 3rd Party |
| CJY | Azo Dye, Calcium | 2 | 47 | 3rd Party |
| JFN | Atomic Absorption, Calcium | 2 | 3 | 3rd Party |
| JFO | Fluorometric, Calcium | 2 | 1 | 3rd Party |
| JFP | Electrode, Ion Specific, Calcium | 2 | 29 | 3rd Party |
