MycoMEIA 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 G100 Baltimore MD US 21205 |
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 |