Q-STAIN® QSX-Enh CK20 QF32032-004
GUDID 00850036867043
Clone R1001
NOVODIAX, INC.
Cytokeratin IVD, kit, enzyme immunohistochemistry| Primary Device ID | 00850036867043 |
| NIH Device Record Key | a4a86485-fe2e-4c28-a913-9ab11535ce89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Q-STAIN® QSX-Enh CK20 |
| Version Model Number | QF32032-004 |
| Catalog Number | QF32032-004 |
| 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 | |
| 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 | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850036867043 [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 | 2022-02-09 |
| Device Publish Date | 2022-02-01 |
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 [Q-STAIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 Q-STAIN 86565076 5102800 Live/Registered |
Novodiax Inc 2015-03-16 |
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