PEARL DIAGNOSTICS, INC.

FDA Device Registration & Listing · Baltimore, MD, US · Registration 3022929618

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022929618
FEI Number
3022929618
Entity Name
PEARL DIAGNOSTICS, INC.
City/State/Country
Baltimore, MD, US
Establishment Address
1812 Ashland Ave Ste G32, Baltimore, MD 21205, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Pearl Diagnostics, Inc. (Owner Number: 10086492)
Owner / Operator Contact Address
1812 ASHLAND AVE, Suite G32, Baltimore, MD 21205, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MycoMEIA® Aspergillus Assay MycoMEIA® Aspergillus Assay

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOM Antigen, Galactomannan, Aspergillus Spp. Microbiology Class 1 866.3040 2025-11-26
MLH Strip, Hama Igg, Elisa, In Vitro Test System Immunology Class 2 866.5510 2022-11-14

Official Correspondent

Irina Baburina

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pearl Diagnostics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022929618. Last updated year: 2026. Please use registration number 3022929618 when referencing this establishment in official correspondence.
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