Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004741920

FEI Number

3004741920

Entity Name

ARUP LABORATORIES

City/State/Country

Salt Lake City, UT, US

Establishment Address

500 Chipeta Way, Mail Code 241, Salt Lake City, UT 84108, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARUP Laboratories (Owner Number: 10050613)

Owner / Operator Contact Address

500 Chipeta Way, Salt Lake City, UT 84108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P190033

All Registered Proprietary Names

AAV5 DetectCDx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWQ	Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors	Unknown	Class 3	N/A	2023-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARUP Laboratories

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3031365458	WOMED SAS	Montpellier Herault, FR
3009999323	STORE-ALL LOGISTICS LTD	Slieverue Kilkenny, IE
3008478369	FERROSAN MEDICAL DEVICES A/S	Soeborg Hovedstaden, DK
3028907862	XVIVO PERFUSION, INC.	Aurora, CO, US
3009969279	Medifocus Inc	Columbia, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004741920. Last updated year: 2026. Please use registration number 3004741920 when referencing this establishment in official correspondence.