| Primary Device ID | 05055331333360 | 
| NIH Device Record Key | 115dd353-b8db-404c-820c-92c9778ae296 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Novocastra | 
| Version Model Number | CD21-2G9-L-U | 
| Catalog Number | NCL-L-CD21-2G9-U | 
| 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 | 
| 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 | |
| Phone | +1(800)2480123 | 
| tech.support@leicabiosystems.com | 
| 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 | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05055331333360 [Primary] | 
| NJT | Immunohistochemistry Reagents And Kits | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-08-07 | 
| Device Publish Date | 2023-07-28 | 
| 05055331329707 | NCL-L-S100-167 is intended for the qualitative identification by light microscopy of S-100B prot | 
| 05055331335852 | NCL-L-WT1-562-U is intended for the qualitative identification by light microscopy of human Wilm | 
| 05055331335845 | NCL-L-VIM-V9-U is intended for the qualitative identification by light microscopy of human vimen | 
| 05055331335838 | NCL-L-TYROS-U is intended for the qualitative identification by light microscopy of Tyrosinase m | 
| 05055331335821 | NCL-L-TTF-1-U is intended for the qualitative identification by light microscopy of Thyroid Tran | 
| 05055331335814 | NCL-L-TPO-U is intended for the qualitative identification by light microscopy of Thyroid Peroxi | 
| 05055331335807 | NCL-L-TdT-339-U is intended for the qualitative identification by light microscopy of human term | 
| 05055331335791 | NCL-L-SYNAP-299-U is intended for the qualitative identification by light microscopy of Synaptop | 
| 05055331335777 | NCL-L-SMA-U is intended for the qualitative identification by light microscopy of human alpha sm | 
| 05055331335760 | NCL-L-S100-167-U is intended for the qualitative identification by light microscopy of S-100B pr | 
| 05055331335753 | NCL-L-PTH-488-U is intended for the qualitative identification by light microscopy of human para | 
| 05055331335746 | NCL-L-PSA-431-U is intended for the qualitative identification by light microscopy of human pros | 
| 05055331335715 | NCL-L-PMS2-U is intended for the qualitative identification by light microscopy of PMS2 molecule | 
| 05055331335708 | NCL-L-PLAP-8A9-U is intended for the qualitative identification by light microscopy of Placental | 
| 05055331335678 | NCL-L-PGP9.5-U is intended for the qualitative identification by light microscopy of Protein Gen | 
| 05055331335562 | NCL-L-PAX-5-U is intended for the qualitative identification by light microscopy of human Pax-5 | 
| 05055331334077 | NCL-L-p63-U is intended for the qualitative identification by light microscopy of human p63 in p | 
| 05055331334060 | NCL-L-p53-DO7-U is intended for the qualitative identification by light microscopy of p53 protei | 
| 05055331334053 | NCL-L-OCT3/4-U is intended for the qualitative identification by light microscopy of Oct-3/4 in | 
| 05055331334046 | NCL-L-NF200-N52-U is intended for the qualitative identification by light microscopy of NF-H (20 | 
| 05055331334039 | NCL-L-NapsinA-U is intended for the qualitative identification by light microscopy of Napsin A m | 
| 05055331334022 | NCL-L-Myf-4-U is intended for the qualitative identification by light microscopy of Myf-4 (Rhabd | 
| 05055331334015 | NCL-L-MUM1-U is intended for the qualitative identification by light microscopy of human multipl | 
| 05055331334008 | NCL-L-MSH6-U is intended for the qualitative identification by light microscopy of Mismatch Repa | 
| 05055331333995 | NCL-L-MSH2-612-U is intended for the qualitative identification by light microscopy of Mismatch | 
| 05055331333988 | NCL-L-MSA-594-U is intended for the qualitative identification by light microscopy of muscle spe | 
| 05055331333971 | NCL-L-MLH1-U is intended for the qualitative identification by light microscopy of Mismatch Repa | 
| 05055331333964 | NCL-L-MESO-U is intended for the qualitative identification by light microscopy of Mesothelin mo | 
| 05055331333940 | NCL-L-MelanA-U is intended for the qualitative identification by light microscopy of human melan | 
| 05055331333933 | NCL-L-LL002-U is intended for the qualitative identification by light microscopy of Cytokeratin | 
| 05055331333926 | NCL-L-LCA-U is intended for the qualitative identification by light microscopy of human CD45 ant | 
| 05055331333919 | NCL-L-LAM-578-U is intended for the qualitative identification by light microscopy of lambda lig | 
| 05055331333902 | NCL-L-Ki67-MM1-U is intended for the qualitative identification by light microscopy of Ki67 Anti | 
| 05055331333896 | NCL-L-KAP-581-U is intended for the qualitative identification by light microscopy of kappa ligh | 
| 05055331333889 | NCL-L-InhibinA-U is intended for the qualitative identification by light microscopy of inhibin a | 
| 05055331333872 | NCL-L-IgM-U is intended for the qualitative identification by light microscopy of immunoglobulin | 
| 05055331333865 | NCL-L-IgG-U is intended for the qualitative identification by light microscopy of human immunogl | 
| 05055331333858 | NCL-L-IgD-U is intended for the qualitative identification by light microscopy of Immunoglobulin | 
| 05055331333841 | NCL-L-IgA-U is intended for the qualitative identification by light microscopy of human immunogl | 
| 05055331333827 | NCL-L-HMB45-U is intended for the qualitative identification by light microscopy of human HMB45 | 
| 05055331333810 | NCL-L-HHV8-LNA-U is intended for the qualitative identification by light microscopy of Human Her | 
| 05055331333773 | NCL-L-GRAN-B-U is intended for the qualitative identification by light microscopy of Granzyme B | 
| 05055331333766 | NCL-L-GCDFP15-U is intended for the qualitative identification by light microscopy of gross cyst | 
| 05055331333759 | NCL-L-FRalpha-U is intended for the qualitative identification by light microscopy of folate rec | 
| 05055331333742 | NCL-L-EZH2-U is intended for the qualitative identification by light microscopy of EZH2 (Enhance | 
| 05055331333711 | NCL-L-END-U is intended for the qualitative identification by light microscopy of human CD34 mol | 
| 05055331333698 | NCL-L-EMA-U is intended for the qualitative identification by light microscopy of Epithelial Mem | 
| 05055331333681 | NCL-L-EGFR-U is intended for the qualitative identification by light microscopy of Epidermal Gro | 
| 05055331333674 | NCL-L-E-Cad-U is intended for the qualitative identification by light microscopy of E-Cadherin m | 
| 05055331333612 | NCL-L-DOG-1-U is intended for the qualitative identification by light microscopy of human DOG-1 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  NOVOCASTRA  78559602  3381731 Live/Registered | LEICA BIOSYSTEMS NEWCASTLE LIMITED 2005-02-03 |