HercepTest™ for the Dako Autostainer
GUDID 05700572031994
HercepTest for the Dako Autostainer
Dako Denmark ApS
C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistry| Primary Device ID | 05700572031994 |
| NIH Device Record Key | d58678d3-2469-46a9-b4e6-7f22e757157b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HercepTest™ for the Dako Autostainer |
| Version Model Number | K5207 |
| Company DUNS | 305047466 |
| Company Name | Dako Denmark ApS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05700572031994 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P980018
FDA Product Code
| MVC | System, Test, Her-2/Neu, Ihc |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2014-09-15 |
Devices Manufactured by Dako Denmark ApS
| 05700571106938 - FLEX Mono Rb A-Hu Cyclin D1, Cl EP12, RTU (Dako Omnis) | 2020-09-25 FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Dako Omnis) |
| 05700571107034 - FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis) | 2020-09-25 FLEX Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5 Ready-to-Use (Dako Omnis) |
| 05700571107041 - FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis) | 2020-09-25 FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-Use (Dako Omnis) |
| 05700571107065 - FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis) | 2020-09-25 FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Dako Omnis) |
| 05700571108451 - Artisan Link Pro | 2020-09-25 Artisan Link Pro |
| 05700571112571 - Dako CoverStainer | 2020-09-25 Dako CoverStainer |
| 05700572013693 - EasyLyse Erythrocyte-Lysing Reagent | 2020-09-25 EasyLyse Erythrocyte-Lysing Reagent |
| 05700572000211 - Poly Rb A-Hu Prealbumin | 2020-09-25 Polyclonal Rabbit Anti-Human Prealbumin |
Trademark Results [HercepTest]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HERCEPTEST 75454146 2383772 Live/Registered |
GENENTECH, INC. 1998-03-20 |
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