Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027062375

FEI Number

3027062375

Entity Name

FORT WORTH DIAGNOSTICS LLC

City/State/Country

Fort Worth, TX, US

Establishment Address

1120 South Freeway, Suite #120, Fort Worth, TX 76104, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fort Worth Diagnostics LLC (Owner Number: 10087769)

Owner / Operator Contact Address

1120 South Freeway, Suite #120, Fort Worth, TX 76104, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stabilized Blood Dilution Matrix Transport Media Dilution Matrix Viral Transport Media Dilution Matrix Group B Streptococcus Primer Set Candida auris Primer Set HSV-2 Primer Set Candida krusei Primer Set Influenza A Primer Set Gardnerella vaginalis Primer Set Ureaplasma Primer Set Candida spp Primer Set Influenza B Primer Set Anaplasma Primer Set HHV-6B Primer Set Adenovirus Primer Set Mycoplasma Primer Set HPV Genotype 31 Primer Set Candida glabrata Primer Set SARS-CoV-2 Primer Set Babesia Primer Set Enterovirus Primer Set RSV Primer Set Megasphaera Primer Set Borrelia miyamotoi Primer Set JCV Primer Set Measles Primer Set Bacillus atrophaeus Primer Set Parechovirus Primer Set BVAB2 Primer Set HHV-6A Primer Set Ehrlichia Primer Set HPV Genotype 45 Primer Set Atopobium vaginae Primer Set HSV-1 Primer Set Asuragen Internal Process Control Primer Set Borrelia Primer Set VZV Primer Set Influenza A H5N1 Primer Set Babesia microti Primer Set HPV Genotype 52 Primer Set HPV Genotype 33 Primer Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2025-06-11
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2023-04-06

Official Correspondent

Winnie Boonyaratanakornkit

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fort Worth Diagnostics 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 3027062375. Last updated year: 2026. Please use registration number 3027062375 when referencing this establishment in official correspondence.