21 CFR 862.1550 — Dye-Indicator, Ph (Urinary, Non-Quantitative)
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1550
Identification
A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 | 11 | |
| LNW | Paper, Obstetric Ph | 1 | 4 | |
| NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | 2 | |
| OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | 1 | 2 | |
| PDS | Amniotic Fluid Protein Immunoassay | 1 | 0 | 3rd Party |
