Antigen Retrieval Solution DNS (50X)

GUDID 00850042030059

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

• Primary Device ID: 00850042030059
• NIH Device Record Key: cfb2fd44-6d06-43a7-a703-137667cb51a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Antigen Retrieval Solution DNS (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	00850042030059 [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.

• 00810202560000 - goldFISH: 2025-08-11 HER2/CSP17 Dual Color Probe
• 00810202560017 - goldFISH: 2025-08-11 ALK Dual Color Break Apart Probe
• 00810202560024 - goldFISH: 2025-08-11 MET/CSP7 Dual Color Probe.
• 00810202560031 - goldFISH: 2025-08-11 MYC Dual Color Break Apart Probe
• 00810202560048 - goldFISH: 2025-08-11 BCL2 Dual Color Break Apart Probe
• 00810202560055 - goldFISH: 2025-08-11 BCL6 Dual Color Break Apart Probe
• 00810202560062 - goldFISH: 2025-08-11 IRF4 Dual Color Break Apart Probe
• 00810202560079 - goldFISH: 2025-08-11 CCND1/IGH Dual Color Dual Fusion Probe