ELISA chromogen/substrate solution

GUDID 04049016151838

EUROIMMUN Medizinische Labordiagnostika AG

Chromogenic/colorimetric substrate reagent IVD

• Primary Device ID: 04049016151838
• NIH Device Record Key: 61574e2c-c66c-493f-9a95-e218d4496188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA chromogen/substrate solution
• Version Model Number: ZE 1200-1012
• 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: true
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016151838 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2025-07-10
• Device Publish Date: 2025-07-02

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

• 04049016139232 - Free Triiodothyronine (FT3) ELISA: 2025-09-22
• 04049016151982 - Mounting medium (IIFT): 2025-07-11
• 04049016152002 - Mounting medium (IIFT): 2025-07-11
• 04049016151791 - ELISA sample buffer: 2025-07-10
• 04049016151838 - ELISA chromogen/substrate solution: 2025-07-10
• 04049016151838 - ELISA chromogen/substrate solution: 2025-07-10
• 04049016151845 - ELISA Stop solution: 2025-07-04
• 04049016137986 - EUROLabWorkstation IFA: 2025-06-30
• 04049016140368 - Dehydroepiandrosterone Sulfate (DHEA-S) ELISA: 2025-06-30