Lumatas Automated Slide Stainer

GUDID 00850042030004

This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemistry such as the application of immuno-reagents (antibodies) to tissue sections.

Lumatas Biosystems, Inc.

Microscope slide stainer IVD

• Primary Device ID: 00850042030004
• NIH Device Record Key: bd15ae0c-b633-43db-86e0-fd626e72b9af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumatas Automated Slide Stainer
• Version Model Number: Titan
• 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 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042030004 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

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

On-Brand Devices [Lumatas Automated Slide Stainer]

• 00850042030011: This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemis
• 00850042030004: This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemis