MOLECULARMD CORPORATION

FDA Device Registration & Listing · Portland, OR, US · Registration 3007125666

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
3007125666
FEI Number
3007125666
Entity Name
MOLECULARMD CORPORATION
City/State/Country
Portland, OR, US
Establishment Address
1341 SW Custer Drive, Portland, OR 97219, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
MolecularMD Corporation, an ICON plc company (Owner Number: 10056701)
Owner / Operator Contact Address
1341 SW Custer Drive, Portland, OR 97219, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173492
PMA Number
N/A

All Registered Proprietary Names

MRDx BCR-ABL Test MRDx BCR-ABL Test Software MRDx Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OYX Bcr/Abl1 Monitoring Test Medical Genetics Class 2 866.6060 2018-01-08

Official Correspondent

Chad Galderisi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MolecularMD Corporation, an ICON plc company
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 3007125666. Last updated year: 2026. Please use registration number 3007125666 when referencing this establishment in official correspondence.
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