Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Regulation 864.1890
0510(k)s in 12 months (0 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in NYQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Cell Marque Corporation | 0 | 2 |
| Dako North America Inc. | 0 | 2 |
| Life Technologies Corporation | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2017 | Cell Marque Corporation Her2/Neu (EP3);
0.5 mL Catalog number 237R-25;
1.0 mL Catalog number 237R-26;
7.0 mL Catalog number 237R-28.
Immunology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Rea Terminated |
NYQ | None listed |
| Jun 1, 2017 | Cell Marque Corporation Her2/Neu (c-erbB-2) (CB-1 1);
7.0 mL Catalog number 237M-18.
In vitro diagnostic use - Analyte Specific Reagent
Immunology - Analyte Specific Reagent Terminated |
NYQ | None listed |
| Jun 10, 2016 | Dako North America Inc. Dako HER2 CISH pharmDx Kit, product code: SK 109
Product Usage:
For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directl Terminated |
NYQ | None listed |
| Feb 26, 2014 | Dako North America Inc. Product Name: HER2 CISH pharmDx Kit
Catalog/Model number: SK109, lot 20000910
Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization o Terminated |
NYQ | None listed |
| Aug 26, 2013 | Life Technologies Corporation HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic Terminated |
NYQ | None listed |
| Jan 11, 2012 | Life Technologies Corporation SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com***
Product Usage: The SPOT-Light HER2 C Terminated |
NYQ | None listed |
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