Home › Device types › GNP
Antiserum, Cf, Epstein-Barr Virus
FDA product code GNP · Class 1 · Microbiology
6
Registered devices
0
Adverse events
2
Recalls
20
510(k) clearances
Devices with this code
Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit — Gold Standard Diagnostics CorporationGold Standard Diagnostics Is-EBV-EA-D IgG Test Kit — Gold Standard Diagnostics CorporationDiamedix — DIAMEDIX CORPORATIONBio-Rad Platelia — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.MERIFLUOR EBV VCA IgG IFA — MERIDIAN BIOSCIENCE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-05 | Diamedix Corporation | Contains a gel-like contaminant that may affect product performance. |
| 2014-10-20 | Diamedix Corporation | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
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