MycoMEIA Aspergillus Assay Uncoated Plates

Basic Information

• Brand Name: MycoMEIA Aspergillus Assay Uncoated Plates
• Primary DI: 00860009979574
• Version / Model: 25101
• Catalog Number: 25101
• Company Name: Pearl Diagnostics
• Labeler DUNS: 079332340
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-16
• Public Version: 1
• Public Version Date: 2026-03-24
• Public Version Status: New
• Public Device Record Key: d16903e2-8107-42c0-b6d8-4c7c306ba2d9

Device Description

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. Uncoated plates are used to fill in empty spaces if a partial assay plate is being used.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOM	Antigen, Galactomannan, Aspergillus Spp.	Microbiology	866.3040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51988	Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of galactomannan antigens from multiple species of the fungus Aspergillus, which may include Aspergillus niger, Aspergillus flavus, Aspergillus terreus and/or Aspergillus fumigatus, in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009979574	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243496	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius