ihcDirect® Cytokeratin 8/18 Ab Conjugate 15mL K31001-015

GUDID 00850030934123

Clone C94

NOVODIAX, INC.

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• Primary Device ID: 00850030934123
• NIH Device Record Key: 242264f2-235a-4e4e-96ba-d782c6a5ea06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ihcDirect® Cytokeratin 8/18 Ab Conjugate 15mL
• Version Model Number: H31001-R015
• Catalog Number: K31001-015
• 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
• 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: 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	00850000596177 [Previous]
GS1	00850030934123 [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

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