pearldx.comMycoMEIA Aspergillus Assay
Pearl Diagnostics, Inc.
PEARL DIAGNOSTICS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022929618 | 3022929618 | PEARL DIAGNOSTICS, INC. | 1 | N | 2026-01-01 | 1812 Ashland Ave Ste G32 Baltimore MD US 21205 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860009979543 | MycoMEIA Aspergillus Assay - 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. | +1-317-413-3465 | info@pearldx.com |
| 00860009979550 | MycoMEIA Aspergillus Assay Sample Processing Columns - 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. Urine is first processed through Sample Processing Columns to eliminate an inhibitor of antibody-antigen recognition. | +1-317-413-3465 | info@pearldx.com |
| 00860009979567 | MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution - 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. 25X Concetrated Wash solution is diluted to wash the asssay plates. | +1-317-413-3465 | info@pearldx.com |
| 00860009979574 | MycoMEIA Aspergillus Assay Uncoated Plates - 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. | +1-317-413-3465 | info@pearldx.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 311090 | 1100067635 | K243496 | MycoMEIA Aspergillus Assay | NOM | 2025-08-01 |
| 311090 | 1305966699 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NOM | 1 | 2025-08-01 |
PMN#
GUDID#
MycoMEIA Aspergillus Assay - 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.
2026-03-16
MycoMEIA Aspergillus Assay Sample Processing Columns - 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. Urine is first processed through Sample Processing Columns to eliminate an inhibitor of antibody-antigen recognition.
2026-03-16
MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution - 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. 25X Concetrated Wash solution is diluted to wash the asssay plates.
2026-03-16
MycoMEIA Aspergillus Assay Uncoated Plates - 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.
2026-03-16