OOI
Revogene
- Advisory panel
- Clinical Chemistry
- Total cleared
- 14
Adverse events under product code OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OOI
- K243922 — Revogene
- K222779 — Revogene
- K220480 — Revogene
- K170558 — revogene
- K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
- K160517 — ARIES System
- K151917 — ARIES System
- K151690 — Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
- K140447 — BD VIPER LT SYSTEM
- K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
- K113319 — ROTOR-GENE Q MDX
- K102314 — 3M INTEGRATED CYCLER (110V) & (220V)
- K093383 — NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
- K092705 — ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
Data sourced from openFDA. This site is unofficial and independent of the FDA.