Titan Prime Universal AP Polymer Detection Kit with Fast Red

GUDID 00850042030202

A Detection System Kit containing four components. Polymer based detection system used in conjunction with Fast Red chromogen to allow for the visualization of tissue samples.

Lumatas Biosystems, Inc.

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• Primary Device ID: 00850042030202
• NIH Device Record Key: df98a04a-14cd-456d-8c5a-3022c0fd4fc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Prime Universal AP Polymer Detection Kit with Fast Red
• Version Model Number: 1
• Company DUNS: 080169635
• Company Name: Lumatas Biosystems, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042030202 [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: 2023-11-02
• Device Publish Date: 2023-10-25

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• 00850042030028 - Deparaffinization Solution: 2023-11-02 Removes the paraffin from formalin fixed, paraffin embedded tissue sections
• 00850042030042 - Antigen Retrieval Solution Neutral (50X): 2023-11-02 Antigen Retrieval (50X) buffer used for antigen unmasking. Antigen unmasking is required for epitope recognition by the primary
• 00850042030059 - Antigen Retrieval Solution DNS (50X): 2023-11-02 Antigen Retrieval (50X) buffer used for antigen unmasking. Antigen unmasking is required for epitope recognition by the primary
• 00850042030066 - Endogenous Peroxidase Blocker: 2023-11-02 Reagent that aids in the blocking of endogenous peroxidase activity within tissue samples
• 00850042030080 - Phosphate Buffered Saline with Tween 20 (20X): 2023-11-02 Washing buffer. Also aids in reagent spreading on tissue samples.
• 00850042030097 - Titan Prime Universal HRP Polymer Detection Kit with DAB: 2023-11-02 A Detection System Kit containing four components. Polymer based detection system used in conjunction with DAB chromogen to all