21 CFR 862.1050 — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1050
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 | 26 | 3rd Party |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 11 | 3rd Party |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 124 | 3rd Party |
| CJH | Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 1 | 3rd Party |
| CJI | Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 0 | 3rd Party |
| CJK | Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 1 | 3rd Party |
| CJL | Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 1 | 3rd Party |
| CJO | Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 4 | 3rd Party |
| CKF | Phenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 2 | 3rd Party |
| NEO | System, Test, Osteocalcin | 2 | 2 | 3rd Party |
