Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009178048

FEI Number

3009178048

Entity Name

DIAGNOSTICS DIRECT LLC

City/State/Country

Stone Harbor, NJ, US

Establishment Address

373 96th St Unit C, Stone Harbor, NJ 08247, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diagnostics Direct LLC (Owner Number: 10037928)

Owner / Operator Contact Address

359 96th Street, # 303, Stone Harbor, NJ 08247, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102400

PMA Number

N/A

All Registered Proprietary Names

SYPHILIS HEALTH CHECK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2011-12-16

Official Correspondent

Norman Proulx

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diagnostics Direct LLC

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 3009178048. Last updated year: 2026. Please use registration number 3009178048 when referencing this establishment in official correspondence.