21 CFR 862.1635 — Biuret (Colorimetric), Total Protein
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1635
Identification
A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
Classification Rationale
Class II (special 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 |
|---|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | 2 | 116 | |
| JGP | Lowry (Colorimetric), Total Protein | 2 | 5 | |
| JGQ | Turbidimetric, Total Protein | 2 | 13 | |
| JGR | Refractometric, Total Protein | 2 | 0 |
Special Controls
CEK — Biuret (Colorimetric), Total Protein
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
eCFR
JGP — Lowry (Colorimetric), Total Protein
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
eCFR
JGQ — Turbidimetric, Total Protein
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
eCFR
JGR — Refractometric, Total Protein
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
eCFR
