Deparaffinization Solution

GUDID 00850042030028

Removes the paraffin from formalin fixed, paraffin embedded tissue sections

Lumatas Biosystems, Inc.

Dewaxing solution IVD

• Primary Device ID: 00850042030028
• NIH Device Record Key: 4a2b2a13-5c63-4b97-9f6c-cfb576636369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deparaffinization Solution
• 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	00850042030028 [Package]; Contains: 00850042030035; Package: [2 Units]; In Commercial Distribution
GS1	00850042030035 [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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• 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