Novocastraâ„¢ NCL-L-CK19
GUDID 05055331323026
NCL-L-CK19 is intended for the qualitative identification by light microscopy of human cytokeratin 19 intermediate filament protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
Cytokeratin IVD, antibody| Primary Device ID | 05055331323026 |
| NIH Device Record Key | c53cf9b7-93f3-4a27-b6d5-97524b3f684b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Novocastraâ„¢ |
| Version Model Number | CK19-L-U |
| Catalog Number | NCL-L-CK19 |
| Company DUNS | 397134693 |
| Company Name | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com | |
| Phone | +1(800)2480123 |
| tech.support@leicabiosystems.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055331323026 [Primary] |
FDA Product Code
| NJT | Immunohistochemistry Reagents And Kits |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-03 |
| Device Publish Date | 2021-04-23 |
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| 05055331328410 | NCL-L-HHV8-LNA is intended for the qualitative identification by light microscopy of Human Herpe |
| 05055331326423 | NCL-L-CD71-309 is intended for the qualitative identification by light microscopy of human CD71 |
| 05055331325808 | NCL-L-CD31-607 is intended for the qualitative identification by light microscopy of human CD31 |
| 05055331325501 | NCL-L-CD79a-599 is intended for the qualitative identification by light microscopy of human CD79 |
| 05055331323835 | NCL-L-CD5-4C7 is intended for the qualitative identification by light microscopy of human CD5 mo |
| 05055331322906 | NCL-L-CD8-4B11 is intended for the qualitative identification by light microscopy of human CD8 a |
| 05055331322890 | NCL-L-CD8-4B11 is intended for the qualitative identification by light microscopy of human CD8 a |
| 05055331322807 | NCL-L-CD1a-235 is intended for the qualitative identification by light microscopy of human CD1a |
| 05055331322470 | NCL-L-vWF is intended for the qualitative identification by light microscopy of human von Willeb |
| 05055331322319 | NCL-L-CD68 is intended for the qualitative identification by light microscopy of human CD68 anti |
| 05055331320100 | NCL-L-CK5 is intended for the qualitative identification by light microscopy of Cytokeratin 5 mo |
| 05055331318312 | NCL-L-CD99-187 is intended for the qualitative identification by light microscopy of CD99 molecu |
| 05055331317100 | NCL-L-a-SARC is intended for the qualitative identification by light microscopy of Alpha-Sarcogl |
| 05055331316356 | NCL-L-b-SARC is intended for the qualitative identification by light microscopy of Beta-Sarcogly |
| 05055331316226 | NCL-L-bcl-2 is intended for the qualitative identification by light microscopy of human bcl-2 on |
| 05055331315571 | NCL-L-CALRET-566 is intended for the qualitative identification by light microscopy of human cal |
| 05055331314352 | NCL-L-CD1a-235 is intended for the qualitative identification by light microscopy of human CD1a |
| 05055331313072 | NCL-L-CD5-4C7 is intended for the qualitative identification by light microscopy of human CD5 mo |
| 05055331312631 | NCL-L-CD7-580 is intended for the qualitative identification by light microscopy of human CD7 an |
| 05055331311566 | NCL-L-CK5 is intended for the qualitative identification by light microscopy of Cytokeratin 5 mo |
| 05055331310583 | NCL-L-DOG-1 is intended for the qualitative identification by light microscopy of human DOG-1 in |
| 05055331310439 | NCL-DYS1 is intended for the qualitative identification by light microscopy of Dystrophin (Rod D |
| 05055331309174 | NCL-L-FRalpha is intended for the qualitative identification by light microscopy of folate recep |
| 05055331308023 | NCL-L-IgA is intended for the qualitative identification by light microscopy of human immunoglob |
| 05055331306548 | NCL-MEROSIN is intended for the qualitative identification by light microscopy of Merosin Lamini |
| 05055331305619 | NCL-L-N-Cad is intended for the qualitative identification by light microscopy of N-Cadherin mol |
| 05055331302076 | The Novocastraâ„¢ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for |
| 05055331302052 | The Novocastraâ„¢ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for |
| 05055331302045 | The Novocastraâ„¢ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for |
| 05055331301482 | NCL-SPEC1 is intended for the qualitative identification by light microscopy of Spectrin by immu |
| 05055331300096 | NCL-L-WT1-562 is intended for the qualitative identification by light microscopy of human Wilmsâ |
| 05055331326850 | NCL-L-CEA-609 is intended for the qualitative identification by light microscopy of carcinoembry |
| 05055331326478 | NCL-L-CHROM-430 is intended for the qualitative identification by light microscopy of chromogran |
| 05055331326454 | NCL-L-B-CAT is intended for the qualitative identification by light microscopy of human beta-cat |
| 05055331326416 | NCL-L-CK17 is intended for the qualitative identification by light microscopy of human cytokerat |
| 05055331325518 | NCL-L-CD15-605 is intended for the qualitative identification by light microscopy of human CD15 |
| 05055331323712 | NCL-L-CD163 is intended for the qualitative identification by light microscopy of human CD163 an |
| 05055331323682 | NCL-L-TdT-339 is intended for the qualitative identification by light microscopy of human termin |
| 05055331323149 | NCL-L-LCA is intended for the qualitative identification by light microscopy of human CD45 antig |
| 05055331323132 | NCL-L-LCA is intended for the qualitative identification by light microscopy of human CD45 antig |
| 05055331322531 | NCL-L-S100p is intended for the qualitative identification by light microscopy of S100 protein i |
| 05055331321770 | NCL-L-VIM-V9 is intended for the qualitative identification by light microscopy of human vimenti |
| 05055331320308 | NCL-L-E-Cad is intended for the qualitative identification by light microscopy of E-Cadherin mol |
| 05055331320063 | NCL-L-p63 is intended for the qualitative identification by light microscopy of human p63 in par |
| 05055331319326 | NCL-L-HMB45 is intended for the qualitative identification by light microscopy of human HMB45 an |
| 05055331318572 | NCL-L-MSA-594 is intended for the qualitative identification by light microscopy of muscle speci |
| 05055331318541 | NCL-L-Hpylori is intended for the qualitative identification by light microscopy of Helicobacter |
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Trademark Results [Novocastra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVOCASTRA 78559602 3381731 Live/Registered |
LEICA BIOSYSTEMS NEWCASTLE LIMITED 2005-02-03 |
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