Q-STAIN® QSX-Enh-F CD34 QF31046-004
GUDID 00850036867449
Clone QBEND/10
NOVODIAX, INC.
CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody CD34 cell marker IVD, antibody| Primary Device ID | 00850036867449 |
| NIH Device Record Key | e2fc5434-75cc-46de-89b8-3844aaaaa5bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Q-STAIN® QSX-Enh-F CD34 |
| Version Model Number | QF31046-004 |
| Catalog Number | QF31046-004 |
| 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 | true |
| 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 | |
| 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 |
| Total Volume | 4 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 |
| 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 | 00850036867449 [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 | 2023-03-28 |
| Device Publish Date | 2023-03-20 |
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 [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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