Panels › Microbiology › Product code QFO · Class 2
Zika Virus Serological Reagents
Regulation 866.3935
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QFO
| Company | 510(k)s | Recalls |
|---|---|---|
| Chembio Diagnostic Systems | 1 | 0 |
| DiaSorin, Inc. | 1 | 0 |
| InBios International, Inc. | 1 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2020 | K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader Chembio Diagnostic Systems | QFO |
| Oct 28, 2019 | K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set DiaSorin, Inc. | QFO |
| Jul 17, 2019 | K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Qua Siemens Healthcare Diagnostics, Inc. | QFO |
| May 23, 2019 | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. | QFO |
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