21 CFR 866.5040 — Albumin, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5040
Identification
An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
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 § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | 2 | 37 | |
| DDZ | Albumin, Fitc, Antigen, Antiserum, Control | 2 | 4 | |
| DFJ | Albumin, Rhodamine, Antigen, Antiserum, Control | 2 | 0 |
Special Controls
DCF — Albumin, Antigen, Antiserum, Control
*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 § 866.9.
eCFR
DDZ — Albumin, Fitc, Antigen, Antiserum, Control
*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 § 866.9.
eCFR
DFJ — Albumin, Rhodamine, Antigen, Antiserum, Control
*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 § 866.9.
eCFR
