QGUClass II
Hemoglobin For Donor Testing
Hematology · 21 CFR 864.7500
Assays hemoglobin concentration test for blood donors.
MDR events7All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
7 adverse event reports on file
- ORSENSE NBM-200 NON-INVASIVE HEMOGLOBIN MONITORJul 6, 2026InjuryOrsense Ltd.MW5190283
- NBM-200Mar 14, 2026MalfunctionOrsense Ltd.3007358963-2026-00001
- NBM-200Mar 14, 2026MalfunctionOrsense Ltd.3007358963-2026-00002
- ORSENSEJun 11, 2025InjuryOrsense LtdMW5171349
- THUMB HGB MONITORJan 7, 2025MalfunctionOrsense Ltd.MW5164404
- THUMB HGB MONITORJan 7, 2025MalfunctionOrsense Ltd.MW5164405
- FINGER SENSOR USED BY ONEBLOOD DONATION CENTERJun 28, 2022MalfunctionUnkMW5110608
Event type breakdown
Malfunction5
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.