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MycoMEIA Aspergillus Assay Uncoated Plates 25101

by Pearl Diagnostics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009979574 UDI-DI Date16 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MycoMEIA Aspergillus Assay Uncoated Plates
Generic Name
Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
25101
Primary DI / UDI-DI
00860009979574
510(k) Number
FDA Product Code
NOM
GMDN Term
Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)
Device Class
Class I
Regulation Number
866.3040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243496)

Other devices from Pearl Diagnostics, Inc.

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No