Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009637528

FEI Number

3009637528

Entity Name

UPS Supply Chain Solutions, Inc.

City/State/Country

Mira Loma, CA, US

Establishment Address

11811 Landon Drive, Suite 100, Mira Loma, CA 91752, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

UPS Supply Chain Solutions, Inc. (Owner Number: 10038314)

Owner / Operator Contact Address

12380 Morris Road, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K083383

PMA Number

N/A

All Registered Proprietary Names

VITEK® 2 CBC VITEK® 2 YST VITEK® 2 BCL BACT/ALERT® BPN BACT/ALERT® BPA VITEK® 2 AST-GN76 VITEK® 2 AST-GN99 VITEK® 2 AST-GN49 VITEK® 2 AST-GN73 VITEK® 2 AST-GN68 VITEK® 2 AST-GN74 VITEK® 2 AST-GN80 VITEK® 2 AST-GN69 VITEK® 2 AST-GN48 VITEK® 2 AST-GN87 VITEK® 2 AST-N800 VITEK® 2 AST-GN90 VITEK® 2 AST-GN67 VITEK® 2 AST-N802 VITEK® 2 AST-GN92 VITEK® 2 AST-GN95 VITEK® 2 AST-GN81 VITEK® 2 AST-GN86 VITEK® 2 AST-GN77 VITEK® 2 AST-N801 VITEK® 2 AST-GN75 VITEK® 2 AST-GN82 VITEK® 2 AST-GN66 VITEK® 2 AST-GN84 VITEK® 2 AST-GN70 VITEK® 2 AST-GN91 VITEK® 2 GP VITEK® 2 AST-GN79 VITEK® 2 AST-ST02 VITEK® 2 AST-GN73 VITEK® 2 AST-GN70 VITEK® 2 AST-GN82 VITEK® 2 AST-GN83 VITEK® 2 AST-GN92 VITEK® 2 AST-GN81 VITEK® 2 AST-GN99 VITEK® 2 AST-GN93 VITEK® 2 AST-GN90 VITEK® 2 AST-GN80 VITEK® 2 AST-N802 VITEK® 2 AST-GN67 VITEK® 2 AST-N800 VITEK® 2 AST-GN68 VITEK® 2 AST-GN74 VITEK® 2 AST-GN87 VITEK® 2 AST-GN76 VITEK® 2 AST-GN66 VITEK® 2 AST-GN69 VITEK® 2 AST-GN84 VITEK® 2 AST-GN86 VITEK® 2 AST-GN95 VITEK® 2 AST-GN49 VITEK® 2 AST-N801 VITEK® 2 AST-GN91 VITEK® 2 AST-GN48 VITEK® 2 AST-GN77 VITEK® 2 AST-GN71 VITEK® 2 AST-GN75 VITEK® 2 AST-GP72 VITEK® 2 AST-GP75 VITEK® 2 AST-GP71 VITEK® 2 AST-GP78 VITEK® 2 AST-GP67 BACT/ALERT® I FA PLUS BACT/ALERT® AST BACT/ALERT® i FN PLUS BACT/ALERT® i LYM BACT/ALERT® NST BACT/ALERT® FA PLUS VITEK® 2 AST-N800 VITEK® 2 AST-GN99 VITEK® 2 AST-GN76 VITEK® 2 AST-GN80 VITEK® 2 AST-GN69 VITEK® 2 AST-GN77 VITEK® 2 AST-GN92 VITEK® 2 AST-GN81 VITEK® 2 AST-GN73 VITEK® 2 AST-GN90 VITEK® 2 AST-GN84 VITEK® 2 AST-GN91 VITEK® 2 AST-GN66 VITEK® 2 AST-GN87 VITEK® 2 AST-GN74 VITEK® 2 AST-GN93 VITEK® 2 AST-GN79 VITEK® 2 AST-GN83 VITEK® 2 AST-GN70 VITEK® 2 AST-GN95 VITEK® 2 AST-GN68 VITEK® 2 AST-GN82 VITEK® 2 AST-N801 VITEK® 2 AST-N802 VITEK® 2 AST-GN67 VITEK® 2 AST-GP74 VITEK® 2 AST-GP68 BACT/ALERT® FN PLUS VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GP78 VITEK® 2 AST-GP74 VITEK® 2 AST-N203 VITEK® 2 AST-N290 VITEK® 2 AST-YS08 VITEK® 2 AST-N233 VITEK®2 AST-GN96 VITEK® 2 AST-N314 VITEK® 2 AST-ST03 VITEK® 2 AST-N374 VITEK® 2 AST-N417 VITEK® 2 AST-XN12 VITEK® 2 AST-N397 VITEK® 2 AST-N412 VITEK®2 AST-GP79 VITEK® 2 AST-P592 VITEK® 2 AST-GN77 VITEK® 2 AST-GN67 VITEK® 2 AST-N800 VITEK® 2 AST-GN87 VITEK® 2 AST-GN66 VITEK® 2 AST-GN92 VITEK® 2 AST-N801 VITEK® 2 AST-GN86 VITEK® 2 AST-GN76 VITEK® 2 AST-GN84 VITEK® 2 AST-GN99 VITEK® 2 AST-GN90 VITEK® 2 AST-GN69 VITEK® 2 AST-GN82 VITEK® 2 AST-GN95 VITEK® 2 AST-GN71 VITEK® 2 ANC VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-XN15 VITEK® 2 AST-N801 VITEK® 2 AST-XN09 VITEK® 2 AST-XN08 VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GP78 VITEK® 2 AST-GP71 VITEK® 2 AST-GP75 VITEK® 2 AST-GP67 BACT/ALERT® FA PLUS VITEK® 2 AST-GP78 VITEK® 2 AST-N801 VITEK® 2 AST-N802 VITEK® 2 AST-N800 VITEK® 2 AST-GP75 VITEK® 2 AST-XN15 VITEK® 2 AST-N801 VITEK® 2 AST-XN08 VITEK® 2 AST-XN09 VITEK® 2 AST-N801 VITEK® 2 AST-N802 VITEK® 2 AST-GN84 VITEK® 2 AST-GN76 VITEK® 2 AST-GN80 VITEK® 2 AST-GN75 VITEK® 2 AST-GN79 VITEK® 2 AST-XN15 VITEK® 2 AST-GN87 VITEK® 2 AST-GN14 VITEK® 2 AST-GN67 VITEK® 2 AST-GN66 VITEK® 2 AST-GN93 VITEK® 2 AST-GN92 VITEK® 2 AST-GN86 VITEK® 2 AST-GN68 VITEK® 2 AST-GN73 VITEK® 2 AST-GN49 VITEK® 2 AST-GN71 VITEK® 2 AST-GN70 VITEK® 2 AST-GN91 VITEK® 2 AST-GN95 VITEK® 2 AST-GN69 VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GP72 VITEK® 2 AST-GP67 VITEK® 2 AST-GP75 VITEK® 2 AST-GP78 VITEK® 2 AST-GP71 BACT/ALERT® PF PLUS VITEK® 2 AST-GP71 VITEK® 2 AST-GP67 VITEK® 2 AST-GP75 VITEK® 2 AST-GP75 VITEK® 2 AST-GP78 VITEK® 2 AST-N801 VITEK® 2 AST-GN99 VITEK® 2 AST-GN84 VITEK® 2 AST-GN93 VITEK® 2 AST-GN91 VITEK® 2 AST-XN09 VITEK® 2 AST-GN90 VITEK® 2 AST-XN08 VITEK® 2 AST-GN92 VITEK® 2 AST-XN04 VITEK® 2 AST-GN83 VITEK® 2 AST-GN75 VITEK® 2 AST-GN74 VITEK® 2 AST-GN48 VITEK® 2 AST-GN87 VITEK® 2 AST-GN71 VITEK® 2 AST-GN80 VITEK® 2 AST-N802 VITEK® 2 AST-GN79 VITEK® 2 AST-GN70 VITEK® 2 AST-XN06 VITEK® 2 AST-GN82 VITEK® 2 AST-GN81 VITEK® 2 AST-GN73 VITEK® 2 AST-N800 VITEK® 2 AST-GP71 VITEK® 2 AST-GP78 VITEK® 2 AST-GP75 VITEK® 2 AST-GP67 VITEK® 2 AST-GP75 VITEK® 2 AST-GP72 VITEK® 2 AST-GP71 VITEK® 2 AST-GP78 VITEK® 2 GN VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GP72 VITEK® 2 AST-GP75 VITEK® 2 AST-GP67 VITEK® 2 AST-GP78 VITEK® 2 AST-GP71 VITEK® 2 AST-XN06 VITEK® 2 AST-GN75 VITEK® 2 AST-GN49 VITEK® 2 AST-XN04 VITEK® 2 AST-GN48 VITEK® 2 NH VITEK® 2 AST-GP67 VITEK® 2 AST-GP71 VITEK® 2 AST-GP72 VITEK® 2 AST-GP74 VITEK® 2 AST-GP68

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXB	Kit, Identification, Yeast	Microbiology	Class 1	866.2660	2023-06-02
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2023-11-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-05
LQL	Gram Positive Identification Panel	Microbiology	Class 1	866.2660	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2023-11-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2023-11-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-05
JSP	Kit, Anaerobic Identification	Microbiology	Class 1	866.2660	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-06
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2023-11-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-06
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-06
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2023-11-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-05
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-05
JST	Kit, Fastidious Organisms	Microbiology	Class 1	866.2660	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-02

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
3044853379	UPS Supply Chain Solutions, Inc.	Ostrava-Poruba Ostrava-Mesto, CZ

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080719	Advandx, Inc.	YEAST TRAFFIC LIGHT PNA FISH	2008-09-12
K033458	Becton, Dickinson & CO	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST	2004-05-28
K112000	bioMerieux, Inc.	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26
K010508	Pasco Laboratories, Inc.	PASCO MIC AND MIC/ID PANELS	2001-04-23
K111394	Siemens Healthcare Diagnostics, Inc.	MICROSCAN MICROSTEP	2011-06-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0028-2014	Becton Dickinson & Co. BD Diagnostic Systems	1	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009637528. Last updated year: 2026. Please use registration number 3009637528 when referencing this establishment in official correspondence.