21 CFR 866.5890 — Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5890
Identification
An inter-alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation.
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 § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CZO | Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control | 1 | 0 | |
| DEC | Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control | 1 | 0 |
