Panels › Microbiology › Product code GNP · Class 1
Antiserum, Cf, Epstein-Barr Virus
Regulation 866.3235
0510(k)s in 12 months (20 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GNP
| Company | 510(k)s | Recalls |
|---|---|---|
| Diamedix Corp. | 2 | 2 |
| Pan Bio Pty. , Ltd. | 3 | 0 |
| Amico Lab, Inc. | 2 | 0 |
| Diagnostic Technology, Inc. | 2 | 0 |
| Granbio, Inc. | 2 | 0 |
| Immuno Concepts, Inc. | 2 | 0 |
| Biotech Research Laboratories, Inc. | 1 | 0 |
| Electro-Nucleonics, Inc. | 1 | 0 |
| Electro-Nucleonics Laboratories, Inc. | 1 | 0 |
| Gull Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2018 | Diamedix Corporation Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640 Terminated |
GNP | K981831 |
| Oct 20, 2014 | Diamedix Corporation Diamedix Is-EBV-EA-D IgG Test Kit
Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis o Terminated |
GNP | K981831 |
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