Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011818318

FEI Number

3011818318

Entity Name

Longhorn Vaccines and Diagnostics LLC

City/State/Country

Bethesda, MD, US

Establishment Address

7272 Wisconsin Avenue, Suite 900, Bethesda, MD 20814, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Longhorn Vaccines and Diagnostics LLC (Owner Number: 10077988)

Owner / Operator Contact Address

7272 Wisconsin Avenue, Suite 910, Bethesda, MD 20814, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN170029

PMA Number

N/A

All Registered Proprietary Names

PrimeStore MTM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2020-10-07

Official Correspondent

Jeff Fischer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Longhorn Vaccines and Diagnostics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3017014794	STRATEGIC LAB PARTNERS LLC	Memphis, TN, US
3016764932	ZHEJIANG GENE SCIENCE CO., LTD	shaoxing Zhejiang, CN
3027266036	BLUE LIFE SOLUTIONS, LLC.	Las Vegas, NV, US
3009613136	CEPHEID AB	SOLNA Stockholm, SE
1216735	PURITAN MEDICAL PRODUCTS COMPANY LLC	GUILFORD, ME, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011818318. Last updated year: 2026. Please use registration number 3011818318 when referencing this establishment in official correspondence.