| Device Type ID | 3011 |
| Device Name | System, Test, Beta-2-microglobulin Immunological |
| Regulation Description | Beta-2-microglobulin Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.5630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JZG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3011 |
| Device | System, Test, Beta-2-microglobulin Immunological |
| Product Code | JZG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Beta-2-microglobulin Immunological Test System. |
| CFR Regulation Number | 866.5630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER IRELAND INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 37 |
Imprecision | 8 |
| Total Device Problems | 45 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | Mar-01-2016 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | Aug-22-2015 |
| 3 | The Binding Site Group, Ltd. | II | Apr-03-2018 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |