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.

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

• 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

Devices Manufactured by Lumatas Biosystems, Inc.

• 00850042030004 - Lumatas Automated Slide Stainer: 2023-11-02 This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemistry such as the application of i
• 00850042030011 - Lumatas Automated Slide Stainer: 2023-11-02 This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemistry such as the application of i
• 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