Panels › Immunology › Product code LRM · Class 2
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Regulation 866.5100
0510(k)s in 12 months (29 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in LRM
| Company | 510(k)s | Recalls |
|---|---|---|
| Diamedix Corp. | 3 | 0 |
| The Binding Site, Ltd. | 2 | 0 |
| Bio-Rad Laboratories Inc | 0 | 2 |
| Elias U.S.A., Inc. | 2 | 0 |
| Helix Diagnostics, Inc. | 2 | 0 |
| Hycor Biomedical, Inc. | 2 | 0 |
| 3M Diagnostic Systems, Inc. | 1 | 0 |
| American Laboratory Products Co., Ltd. | 1 | 0 |
| Amersham Corp. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2011 | Bio-Rad Laboratories Inc Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests,
Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA
The Bio-Rad Autoimmune EIA Anti-dsDNA Test Terminated |
LRM | K960091 |
| Mar 14, 2011 | Bio-Rad Laboratories Inc Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests,
Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA
The Bio-Rad Autoimmune EIA Anti-dsDNA Test is Terminated |
LRM | K960091 |
| Mar 5, 2010 | Calbiotech Inc dsDNA IgG ELISA 96 Well Kit, Catalog Number: DD037G
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
LRM | None listed |
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