RESEARCHDX,INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3012177275

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
3012177275
FEI Number
3012177275
Entity Name
RESEARCHDX,INC.
City/State/Country
Irvine, CA, US
Establishment Address
5 Mason, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ResearchDx,Inc. (Owner Number: 10075876)
Owner / Operator Contact Address
5 Mason, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Collection kits Collection kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PDA Investigational Use Only - Clinical Chemistry Unknown Class N N/A 2020-07-06
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2022-04-15

Official Correspondent

Philip Cotter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ResearchDx,Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012177275. Last updated year: 2026. Please use registration number 3012177275 when referencing this establishment in official correspondence.
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