Genabio Diagnostics, Inc.

FDA Regulatory Profile

Genabio Diagnostics, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 5, 2025.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251753GenaCheck COVID-19 Rapid Self-TestSeptember 5, 2025
K240545GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and FentanylAugust 28, 2024