GPNClass I

Antiserum, Typhus Fever

Microbiology · 21 CFR 866.3500

MDR events0All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances1All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Changchun Wancheng Bio-Electron Co., Ltd.
Open, ClassifiedFeb 4, 2026
S. Typhi/Para Typhi A Antigen
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; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Z-1261-2026 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Hillcrest BiologicalsMar 12, 1987
K864110 · RICKETTSIAL IGG AND IGM IFA KIT