ihcDirect® Cytokeratin 7 Ab Conjugate 15mL K32015-015
GUDID 00850030934307
Clone R284
NOVODIAX, INC.
Cytokeratin IVD, kit, enzyme immunohistochemistry| Primary Device ID | 00850030934307 |
| NIH Device Record Key | dc64f949-f46a-4162-9cd5-de85ccae9ef3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ihcDirect® Cytokeratin 7 Ab Conjugate 15mL |
| Version Model Number | H32015-R015 |
| Catalog Number | K32015-015 |
| 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 | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 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 | 00850000596153 [Previous] |
| GS1 | 00850030934307 [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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.