MycoMEIA Aspergillus Assay

Primary DI
00860009979543
Brand
MycoMEIA Aspergillus Assay
Company
Pearl Diagnostics
Model
25100
Catalog number
25100
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.
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOMAntigen, Galactomannan, Aspergillus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOMAntigen, Galactomannan, Aspergillus Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243496000MycoMEIA Aspergillus AssayPearl Diagnostics, Inc.2025-08-01NOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009979543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009979543008600099795438600099795430860009979543

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-317-413-3465info@pearldx.com

Regulatory Flags#

DUNS number
079332340
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009979550MycoMEIA Aspergillus Assay Sample Processing Columns25102251022026-03-16
00860009979567MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution 25101251012026-03-16
00860009979574MycoMEIA Aspergillus Assay Uncoated Plates 25101251012026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009979550MycoMEIA Aspergillus Assay Sample Processing ColumnsPearl DiagnosticsNOM2026-03-16
00860009979567MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution Pearl DiagnosticsNOM2026-03-16
00860009979574MycoMEIA Aspergillus Assay Uncoated Plates Pearl DiagnosticsNOM2026-03-16
03610522189380PlateliaBIO-RADNOM2023-01-08