Product code DEB
- Device name
- Alpha-2-Macroglobulin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5620
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2014-04-16 |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Dade Behring, Inc. | 2008-07-21 |
| K053073 | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | Dade Behring, Inc. | 2006-03-28 |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Beckman Instruments, Inc. | 1998-02-17 |
| K914389 | ALPHA-2 MACROGLOBULIN TEST RID KIT | The Binding Site, Ltd. | 1991-12-20 |
| K896483 | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-12-01 |
| K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | Kent Laboratories, Inc. | 1985-11-27 |
| K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | Cooper Biomedical, Inc. | 1985-05-24 |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | Applications Lab | 1985-03-05 |
| K812493 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO | Dako Corp. | 1981-09-23 |
| K791340 | HUMAN ALPHA2 MACROGLOBULIN | Beckman Instruments, Inc. | 1979-08-16 |
| K772246 | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 |
| K771780 | LAS-R TM | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971674869948 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674869955 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 04050598000872 | α2-Makroglobulin ELISA | Immundiagnostik AG | 2023-06-21 |
| 04050598166103 | α2-Makroglobulin ELISA | Immundiagnostik AG | 2023-06-21 |
| 05415168006873 | Alpha2-macroglobulin | Diagam | 2021-12-07 |
| 05415168003476 | Alpha2-Macroglobulin | Diagam | 2020-01-08 |
| B1761240 | Antiserum to Human Alpha 2 Macroglobulin | KENT LABORATORIES INC | 2016-09-24 |
| 05051700016469 | Human alpha 2 macroglobulin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700017480 | Optilite Alpha-2-macroglobulin Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00842768024412 | Dimension Vista® Flex® reagent cartridge A2MAC | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768029967 | N Antiserum to Human a2-Macroglobulin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 15099590224059 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |