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Reagents, Zika Virus Nucleic Acid

FDA product code POA · Class N · Unknown

3
Registered devices
16
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.

Recent recalls

DateFirmReason
2016-11-16Roche Molecular Systems, Inc.The LightCycler 480 algorithm used for the LightMix Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result f

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.