QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
Device Facts
| Record ID | K896483 |
|---|---|
| Device Name | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK |
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc. |
| Product Code | DEB · Immunology |
| Decision Date | Dec 1, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5620 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
Special Controls
*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 the limitations in § 866.9.
