QSX-Enh-P HER2 (ASR) AP31063-004

GUDID 00850041202419

Clone CB11

NOVODIAX, INC.

C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody

• Primary Device ID: 00850041202419
• NIH Device Record Key: d1070683-4dfd-4b81-bd3f-24fa7c306371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QSX-Enh-P HER2 (ASR)
• Version Model Number: AP31063-004
• Catalog Number: AP31063-004
• 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
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• Phone: 5103423043
• Email: support@novodiax.com
• 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
• 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	00850041202419 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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

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