DEC · Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5890 · Class 1
Overview
| Product Code | DEC |
|---|---|
| Device Name | Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5890 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
