Bio-Rad Laboratories
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories7
Latest Approval2025-04-18
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| PMA | P050048 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-04-18 | View |
| 510(k) | K183446 | BioPlex 2200 Lyme Total | LSR | 2019-03-12 | View |
| 510(k) | K180577 | BioPlex 2200 25-OH Vitamin D Kit | MRG | 2018-06-22 | View |
| 510(k) | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | PUQ | 2017-05-19 | View |
| 510(k) | K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | LIP | 2017-05-11 | View |
| 510(k) | K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | JJY | 2017-01-10 | View |
| 510(k) | K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak | PMN | 2016-05-10 | View |
| 510(k) | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak | PMN | 2016-03-28 | View |
No matching devices.