Alpha-2-Macroglobulin, Antigen, Antiserum, Control
FDA product code DEB · Class II (moderate risk) · 21 CFR 866.5620 · Immunology
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Beckman Instruments, Inc. 2
- Dade Behring, Inc. 2
- Hyland Therapeutic Div., Travenol Laboratories 1
- Kallestad Laboratories, Inc. 1
- Dako Corp. 1
- Applications Lab 1
- Cooper Biomedical, Inc. 1
- Kent Laboratories, Inc. 1
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- The Binding Site, Ltd. 1
- The Binding Site Group , Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140664 | Human ALPHA2-MACROGLOBULIN Kit for Use on SpaplusDEB · Traditional | The Binding Site Group , Ltd. | 04/16/2014SE |
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | Dade Behring, Inc. | 07/21/2008SE |
| K053073 | N Antisera to Human ALPHA2-MACROGLOBULINDEB · Traditional | Dade Behring, Inc. | 03/28/2006SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | Beckman Instruments, Inc. | 02/17/1998SE |
| K914389 | ALPHA-2 Macroglobulin Test Rid KitDEB · Traditional | The Binding Site, Ltd. | 12/20/1991SE |
| K896483 | QM300 ALPHA2 Macroglobulin Antibody PackDEB · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 12/01/1989SE |
| K850683 | 72 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional | Kent Laboratories, Inc. | 11/27/1985SE |
| K851282 | Radial Immunodiffusion Plates ALPHA-2 MacroglobuliDEB · Traditional | Cooper Biomedical, Inc. | 05/24/1985SE |
| K850603 | SPQ Test System for ALPHA(2) MacroglobulinDEB · Traditional | Applications Lab | 03/05/1985SE |
| K812493 | Immunogl. Frct. of Rabbit Antiser.-MacroDEB · Traditional | Dako Corp. | 09/23/1981SE |
| K791340 | Human ALPHA2 MacroglobulinDEB · Traditional | Beckman Instruments, Inc. | 08/16/1979SE |
| K772246 | ALPHA-2-MACROGLOBULIN Nephel. AssayDEB · Traditional | Kallestad Laboratories, Inc. | 12/22/1977SE |
| K771780 | Las-R TMDEB · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 10/04/1977SE |