21 CFR 862.1645 — Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1645
Identification
A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
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 |
|---|---|---|---|---|
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 13 | |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 38 |
