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Dna-Probe, Reagents, Streptococcal

FDA product code MDK · Class 1 · Microbiology

2
Registered devices
4
Adverse events
2
Recalls
4
510(k) clearances

Devices with this code

GROUP A STREPTOCOCCUS — Hologic, Inc.GROUP A STREPTOCOCCUS — Hologic, Inc.

Recent recalls

DateFirmReason
2008-12-30Gen-Probe IncThis recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combinatio
2007-05-02Gen-Probe IncMispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

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