APTITUDE MEDICAL SYSTEMS

FDA Device Registration & Listing · Goleta, CA, US · Registration 3017638293

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
3017638293
FEI Number
3017638293
Entity Name
APTITUDE MEDICAL SYSTEMS
City/State/Country
Goleta, CA, US
Establishment Address
125 Cremona Drive Ste 100, Goleta, CA 93117, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Aptitude Medical Systems (Owner Number: 10087100)
Owner / Operator Contact Address
125 Cremona Drive Ste 100, Goleta, CA 93117, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Metrix Test Swab Metrix COVID/Flu Test Metrix Reader Metrix Reader Metrix COVID-19 Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2025-02-25
QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices Unknown Class N N/A 2025-02-25
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2023-01-20

Official Correspondent

Ryan Candy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aptitude Medical Systems
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-0043-2025 Luminex Molecular Diagnostics Inc N
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Z-0004-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017638293. Last updated year: 2026. Please use registration number 3017638293 when referencing this establishment in official correspondence.
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