Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019946577

FEI Number

3019946577

Entity Name

UPS Supply Chain Solutions, Inc.

City/State/Country

Fairdale, KY, US

Establishment Address

6204 New Cut Road, Fairdale, KY 40118, US

Establishment Type(s)

Remanufacture Medical Device

Owner / Operator

UPS SUPPLY CHAIN SOLUTIONS, INC. (Owner Number: 9073670)

Owner / Operator Contact Address

12380 Morris Road, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221925

PMA Number

N/A

All Registered Proprietary Names

ALERE I STREP A Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit ALERE I STREP A ID NOW COVID-19 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2021-08-02
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2021-08-02
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2021-08-02
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2021-08-02
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2021-08-02
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2021-08-02
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2021-08-02
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2021-08-02
QWR	Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings	Microbiology	Class 2	866.3982	2025-11-21

Official Correspondent

Sam Waltham

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UPS SUPPLY CHAIN SOLUTIONS, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009171251	UPS SUPPLY CHAIN SOLUTIONS, INC.	Louisville, KY, US
3013718871	UPS Supply Chain Solutions, Inc.	Pedricktown, NJ, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019946577. Last updated year: 2026. Please use registration number 3019946577 when referencing this establishment in official correspondence.