TRUE DIAGNOSTICS, INC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3027500452

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
3027500452
FEI Number
3027500452
Entity Name
TRUE DIAGNOSTICS, INC.
City/State/Country
Carlsbad, CA, US
Establishment Address
5919 Farnsworth Ct, Carlsbad, CA 92008, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
True Diagnostics, Inc. (Owner Number: 10058307)
Owner / Operator Contact Address
2782 Loker Ave West, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CVS Health Digital Ovulation Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2024-08-31
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2022-03-23
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2023-11-02

Official Correspondent

Jerry Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01
Z-0001-2023 Jiangsu Well Biotech Co., Ltd. No N
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027500452. Last updated year: 2026. Please use registration number 3027500452 when referencing this establishment in official correspondence.
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