Jiangsu Well Biotech Co.,Ltd.

FDA Regulatory Profile

Jiangsu Well Biotech Co.,Ltd. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0001-2023, Class I) was initiated on August 9, 2022.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0001-2023Class IJiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02August 9, 2022