MYRClass II
Test, Donor, Syphilis, Antigens, Treponemal
Microbiology · 21 CFR 866.3830
MDR events5All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances0All time
Recent MDR events
5 adverse event reports on file
- SYPHILIS TREPONEMAL ANTIBODY TEST (MHA-TP)Feb 4, 2022MalfunctionUnkMW5107223
- TPHA SCREEN TEST CELLSMay 25, 2017MalfunctionImmucor, Inc.1034569-2017-00094
- TPHA SCREEN TEST CELLSSep 22, 2016MalfunctionImmucor, Inc.1034569-2016-00248
- TPHA SCREEN TEST CELLSJun 7, 2016MalfunctionImmucor, Inc.1034569-2016-00129
- AMPCORJun 29, 2000MalfunctionAmpcor Technologies Inc. (ati286009
Event type breakdown
Malfunction5
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 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.