Reagent tray for incubation of slides

GUDID 04049016152125

EUROIMMUN Medizinische Labordiagnostika AG

Assay container IVD, single-use

• Primary Device ID: 04049016152125
• NIH Device Record Key: b6963cb3-7262-4a8c-86c8-dcfd91b7ae9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reagent tray for incubation of slides
• Version Model Number: ZZ 9999-0110-R
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016152125 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2025-12-05
• Device Publish Date: 2025-11-27

On-Brand Devices [Reagent tray for incubation of slides]

• 04049016152125: ZZ 9999-0110-R
• 04049016152101: ZZ 9999-0105-R