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Antiserum, Typhus Fever

FDA product code GPN · Class 1 · Microbiology

2
Registered devices
0
Adverse events
1
Recalls
1
510(k) clearances

Devices with this code

Rickettsia IFA IgM — DIASORIN MOLECULAR LLCRickettsia IFA IgG — DIASORIN MOLECULAR LLC

Recent recalls

DateFirmReason
2025-11-22Changchun Wancheng Bio-Electron Co., Ltd.Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers;

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