Antigen Retrieval Solution Neutral (50X)

GUDID 00850042030042

Antigen Retrieval (50X) buffer used for antigen unmasking. Antigen unmasking is required for epitope recognition by the primary antibody.

Lumatas Biosystems, Inc.

Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD Immunohistochemistry antigen retrieval reagent IVD

• Primary Device ID: 00850042030042
• NIH Device Record Key: 34684fe3-67c8-4736-9565-389f346faa49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Antigen Retrieval Solution Neutral (50X)
• 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: false
• 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 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042030042 [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.

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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): 2023-11-02Antigen Retrieval (50X) buffer used for antigen unmasking. Antigen unmasking is required for epitope recognition by the primary antibody.
• 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
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• 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