Panels › Microbiology › Product code GSM · Class 2
Antisera, Fluorescent, Brucella Spp.
Regulation 866.3085
0510(k)s in 12 months (4 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in GSM
| Company | 510(k)s | Recalls |
|---|---|---|
| Sa Scientific, Inc. | 4 | 0 |
| BD Diagnostic Systems | 0 | 2 |
| Calbiotech Inc | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2010 | Calbiotech Inc Brucella IgM ELISA 96 Well Kit, Catalog Number: BA053M
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
GSM | None listed |
| Mar 5, 2010 | Calbiotech Inc Brucella IgG ELISA 96 Well Kit, Catalog Number: BA052G
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
GSM | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Febrile Antigen Negative Control Terminated |
GSM | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Brucella Postive Control Antiserum (AMS) Terminated |
GSM | None listed |
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