| Primary Device ID | 00860009979567 |
| NIH Device Record Key | 8959054e-56f7-4317-985a-9badff719c4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution |
| Version Model Number | 25101 |
| Catalog Number | 25101 |
| 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 | false |
| 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 |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 30 Degrees Celsius |
| 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 | 2026-03-24The 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. 25X Concetrated Wash solution is diluted to wash the asssay plates. |
| 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 |