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Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA product code PGH · Class 2 · Microbiology

2
Registered devices
1
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

Simplexa™ HSV 1 & 2 Positive Control Pack — DIASORIN MOLECULAR LLCSimplexa™ HSV 1 & 2 Direct — DIASORIN MOLECULAR LLC

Recent recalls

DateFirmReason
2016-02-10Focus Diagnostics IncFocus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL265

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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