ihcDirect® Cytokeratin 7 Ab Conjugate 5mL K32015-005
GUDID 00850030934291
Clone R284
NOVODIAX, INC.
Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry| Primary Device ID | 00850030934291 |
| NIH Device Record Key | 24c1e412-835b-4ab4-8baa-afd9025c34a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ihcDirect® Cytokeratin 7 Ab Conjugate 5mL |
| Version Model Number | H32015-R005 |
| Catalog Number | K32015-005 |
| Company DUNS | 965326957 |
| Company Name | NOVODIAX, INC. |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com | |
| Phone | 5103423043 |
| support@novodiax.com |
Device Dimensions
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850000596146 [Previous] |
| GS1 | 00850030934291 [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 | 2021-08-30 |
| Device Publish Date | 2021-08-20 |
Devices Manufactured by NOVODIAX, INC.
| 00850036867753 - Q-STAIN® QSX-Enh-P WT-1 | 2023-11-29 Clone R1012 |
| 00850036867760 - Q-STAIN® QSX-Enh-F WT-1 | 2023-11-29 Clone R1012 |
| 00850036867777 - Q-STAIN® QSX-Enh-P Gal-3 | 2023-11-29 Clone R105 |
| 00850036867784 - Q-STAIN® QSX-Enh-F Gal-3 | 2023-11-29 Clone R105 |
| 00850036867791 - Q-STAIN® QSX-Enh-P TROP2 | 2023-11-29 Clone R1011 |
| 00850036867807 - Q-STAIN® QSX-Enh-F TROP2 | 2023-11-29 Clone R1011 |
| 00850041202365 - Q-STAIN® QSX-Enh-F CgA | 2023-11-29 Clone R1004 |
| 00850041202372 - Q-STAIN® QSX-Enh-P CgA | 2023-11-29 Clone R1004 |
Trademark Results [ihcDirect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IHCDIRECT 86565063 5124949 Live/Registered |
Novodiax Inc 2015-03-16 |
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