DEB · Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5620 · Class 2
Overview
| Product Code | DEB |
|---|---|
| Device Name | Alpha-2-Macroglobulin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5620 |
| Device Class | Class 2 |
| Review Panel | Immunology |
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.
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 the limitations in § 866.9.
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.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | Apr 16, 2014 | SESE |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Dade Behring, Inc. | Jul 21, 2008 | SESE |
| K053073 | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | Dade Behring, Inc. | Mar 28, 2006 | SESE |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Beckman Instruments, Inc. | Feb 17, 1998 | SESE |
| K914389 | ALPHA-2 MACROGLOBULIN TEST RID KIT | The Binding Site, Ltd. | Dec 20, 1991 | SESE |
| K896483 | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Dec 1, 1989 | SESE |
| K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | Kent Laboratories, Inc. | Nov 27, 1985 | SESE |
| K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | Cooper Biomedical, Inc. | May 24, 1985 | SESE |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | Applications Lab | Mar 5, 1985 | SESE |
| K812493 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO | Dako Corp. | Sep 23, 1981 | SESE |
| K791340 | HUMAN ALPHA2 MACROGLOBULIN | Beckman Instruments, Inc. | Aug 16, 1979 | SESE |
| K772246 | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | Dec 22, 1977 | SESE |
| K771780 | LAS-R TM | Hyland Therapeutic Div., Travenol Laboratories | Oct 4, 1977 | SESE |
Top Applicants
- Dade Behring, Inc. — 2 clearances
- Beckman Instruments, Inc. — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- The Binding Site Group , Ltd. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance
