CD DIAGNOSTICS, INC

FDA Device Registration & Listing · Claymont, DE, US · Registration 3011171357

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
3011171357
FEI Number
3011171357
Entity Name
CD DIAGNOSTICS, INC
City/State/Country
Claymont, DE, US
Establishment Address
650 Naamans Road, Suite 100, Claymont, DE 19703, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CD Diagnostics, Inc (Owner Number: 10047552)
Owner / Operator Contact Address
650 Naamans Road (Suite 100), Claymont, DE 19703, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN180032
PMA Number
N/A

All Registered Proprietary Names

Synovasure Alpha Defensin Lateral Flow Test Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QGN Lateral Flow Immunochromatography Assay For Host Infection Biomarkers Microbiology Class 2 866.3230 2019-05-31

Official Correspondent

Jay Pathak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CD Diagnostics, 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 3011171357. Last updated year: 2026. Please use registration number 3011171357 when referencing this establishment in official correspondence.
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