BIOER Sample Preservative Fluid
Model BSC82X1-A1 · Hangzhou Bioer Technology Co., Ltd. · DI 06973843228143
QBD — Microbial Nucleic Acid Storage And Stabilization Device · Class II · 21 CFR 866.2950
UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
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Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Hangzhou Bioer Technology Co., Ltd.
Nothing in the loaded window.