Q-STAIN® QSX-Enh-P Calponin QP31026-004

GUDID 00850036867333

Clone C126

NOVODIAX, INC.

Calponin protein IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 00850036867333
• NIH Device Record Key: 6445a28d-26f4-4148-a579-b2928c494efc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-STAIN® QSX-Enh-P Calponin
• Version Model Number: QP31026-004
• Catalog Number: QP31026-004
• 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
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850036867333 [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: 2022-05-23
• Device Publish Date: 2022-05-13

Devices Manufactured by NOVODIAX, INC.

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• 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