Home › Device types › MJX
Kit, Serological, Positive Control
FDA product code MJX · Class 1 · Clinical Chemistry
9
Registered devices
2
Adverse events
1
Recalls
7
510(k) clearances
Devices with this code
VITROS — ORTHO CLINICAL DIAGNOSTICSARCHITECT — Abbott GmbHACCESS HIV Ag/Ab combo QC — Beckman Coulter, Inc.ACCURUN® — Lgc Clinical Diagnostics, Inc.RSV Positive Control — MERIDIAN BIOSCIENCE, INC.SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +) — RANDOX LABORATORIES LIMITEDAlinity — Abbott GmbHARCHITECT — Abbott GmbHARCHITECT — Abbott GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-06-22 | Ortho-Clinical Diagnostics | The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negativ |
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