MycoMEIA Aspergillus Assay 25100

GUDID 00860009979543

The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates.

Pearl Diagnostics

Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00860009979543
• NIH Device Record Key: f9e9f83c-0c19-4497-9336-018dc4635910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MycoMEIA Aspergillus Assay
• Version Model Number: 25100
• Catalog Number: 25100
• Company DUNS: 079332340
• Company Name: Pearl Diagnostics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-317-413-3465
• Email: info@pearldx.com
• Phone: +1-317-413-3465
• Email: info@pearldx.com
• Phone: +1-317-413-3465
• Email: info@pearldx.com
• Phone: +1-317-413-3465
• Email: info@pearldx.com
• Phone: +1-317-413-3465
• Email: info@pearldx.com
• Phone: +1-317-413-3465
• Email: info@pearldx.com
• Phone: +1-317-413-3465
• Email: info@pearldx.com
• Phone: +1-317-413-3465
• Email: info@pearldx.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009979543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243496

FDA Product Code

• NOM: Antigen, Galactomannan, Aspergillus Spp.

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: 2026-03-24
• Device Publish Date: 2026-03-16

Devices Manufactured by Pearl Diagnostics

• 00860009979543 - MycoMEIA Aspergillus Assay: 2026-03-24The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates.
• 00860009979543 - MycoMEIA Aspergillus Assay: 2026-03-24 The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. T
• 00860009979550 - MycoMEIA Aspergillus Assay Sample Processing Columns: 2026-03-24 The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. T
• 00860009979567 - MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution: 2026-03-24 The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. T
• 00860009979574 - MycoMEIA Aspergillus Assay Uncoated Plates: 2026-03-24 The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. T