Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013718871

FEI Number

3013718871

Entity Name

UPS Supply Chain Solutions, Inc.

City/State/Country

Pedricktown, NJ, US

Establishment Address

7 Gateway Blvd, Pedricktown, NJ 08067, US

Establishment Type(s)

Repack or Relabel 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

K111599

PMA Number

N/A

All Registered Proprietary Names

VITEK® 2 AST-ST02 VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GN82 VITEK® 2 AST-GN91 VITEK® 2 AST-GN77 VITEK® 2 AST-GN70 VITEK® 2 AST-GN80 VITEK® 2 AST-GN48 VITEK® 2 AST-GN93 VITEK® 2 AST-XN06 VITEK® 2 AST-XN04 VITEK® 2 AST-GN76 VITEK® 2 AST-GN74 VITEK® 2 AST-GN71 VITEK® 2 AST-GN68 VITEK® 2 AST-XN04 VITEK® 2 AST-XN06 VITEK® 2 AST-XN08 BACT/ALERT BPN CULTURE BOTTLE BACT/ALERT BPN VITEK® 2 AST-YS05 VITEK® 2 AST-N802 VITEK® 2 AST-GP72 VITEK® 2 AST-GP67 VITEK® 2 AST-GP75 VITEK® 2 AST-GP71 VITEK® 2 AST-GP78 VITEK® 2 AST-XN06 VITEK® 2 AST-GN49 VITEK® 2 AST-GN48 VITEK® 2 AST-GN75 VITEK® 2 AST-XN04 VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GP78 VITEK® 2 AST-GN80 VITEK® 2 AST-GN84 VITEK® 2 AST-N801 VITEK® 2 AST-GN90 VITEK® 2 AST-GN74 VITEK® 2 AST-GN99 VITEK® 2 AST-N802 VITEK® 2 AST-GN48 VITEK® 2 AST-GN87 VITEK® 2 AST-GN68 VITEK® 2 AST-GN91 VITEK® 2 AST-GN70 VITEK® 2 AST-GN66 VITEK® 2 AST-GN76 VITEK® 2 AST-GN73 VITEK® 2 AST-GN81 VITEK® 2 AST-GN69 VITEK® 2 AST-ST02 VITEK® 2 AST-GN83 VITEK® 2 AST-GN71 VITEK® 2 AST-GN93 VITEK® 2 AST-GN95 VITEK® 2 AST-GN49 VITEK® 2 AST-GN86 VITEK® 2 AST-N800 VITEK® 2 AST-GN92 VITEK® 2 AST-GN75 VITEK® 2 AST-GN67 VITEK® 2 AST-GN82 VITEK® 2 AST-GN79 VITEK® 2 AST-GN77 VITEK® 2 AST-GP72 VITEK® 2 AST-GP78 VITEK® 2 AST-GP67 VITEK® 2 AST-GP75 VITEK® 2 AST-GP71 BACT/ALERT BPA EU 100 BTLS BACT/ALERT BPN EU 100 BTLS VITEK® 2 AST-N800 VITEK® 2 AST-N801 VITEK® 2 AST-N802 VITEK® 2 ID GP VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-ST01 VITEK® 2 AST-ST02 VITEK® 2 AST-GP75 VITEK® 2 AST-GP67 VITEK® 2 AST-GP78 VITEK® 2 AST-GP71 VITEK® 2 AST-GN71 VITEK® 2 AST-GN99 VITEK® 2 AST-GN74 VITEK® 2 AST-N801 VITEK® 2 AST-N800 VITEK® 2 AST-XN04 VITEK® 2 AST-XN08 VITEK® 2 AST-N802 VITEK® 2 AST-GN92 VITEK® 2 AST-XN06 VITEK® 2 AST-GN81 VITEK® 2 AST-GN79 VITEK® 2 AST-GN73 VITEK® 2 AST-GN87 VITEK® 2 AST-GN48 VITEK® 2 AST-GN90 VITEK® 2 AST-GN93 VITEK® 2 AST-GN70 VITEK® 2 AST-GN80 VITEK® 2 AST-GN75 VITEK® 2 AST-GN91 VITEK® 2 AST-GN82 VITEK® 2 AST-GN83 VITEK® 2 AST-XN09 VITEK® 2 AST-GN84 Saline solution VITEK® 2 AST-XN08 VITEK® 2 AST-XN09 VITEK® 2 AST-N801 VITEK® 2 AST-XN15 VITEK® 2 AST-XN09 VITEK® 2 AST-XN06 VITEK® 2 AST-GN71 VITEK® 2 AST-XN15 VITEK® 2 AST-XN04 VITEK® 2 AST-XN08 VITEK® 2 AST-ST02 VITEK® 2 AST-GP74 VITEK® 2 AST-GP68 VITEK® 2 AST-XN08 VITEK® 2 AST-XN09 VITEK® 2 AST-N801 VITEK® 2 AST-XN15 BACT/ALERT SN CULTURE BOTTLE BACT/ALERT SN (PLASTIC) 100 BTLS BACT/ALERT SN (PLASTIC) VITEK® 2 AST-GN95 VITEK® 2 AST-GN77 VITEK® 2 AST-GN86 VITEK® 2 AST-GN71 VITEK® 2 AST-GN66 VITEK® 2 AST-GN76 VITEK® 2 AST-GN92 VITEK® 2 AST-GN82 VITEK® 2 AST-GN99 VITEK® 2 AST-N800 VITEK® 2 AST-GN67 VITEK® 2 AST-GN84 VITEK® 2 AST-GN90 VITEK® 2 AST-GN87 VITEK® 2 AST-GN69 VITEK® 2 AST-N801 VITEK® 2 AST-XN15 VITEK® 2 AST-GN80 VITEK® 2 AST-GN67 VITEK® 2 AST-GN86 VITEK® 2 AST-GN95 VITEK® 2 AST-GN49 VITEK® 2 AST-GN79 VITEK® 2 AST-GN71 VITEK® 2 AST-GN66 VITEK® 2 AST-GN68 VITEK® 2 AST-GN75 VITEK® 2 AST-GN92 VITEK® 2 AST-GN14 VITEK® 2 AST-GN87 VITEK® 2 AST-GN91 VITEK® 2 AST-GN93 VITEK® 2 AST-GN76 VITEK® 2 AST-GN84 VITEK® 2 AST-GN69 VITEK® 2 AST-GN70 VITEK® 2 AST-GN73 VITEK® 2 AST-GN95 VITEK® 2 AST-XN15 VITEK® 2 AST-GN99 VITEK® 2 ID ANC VITEK® 2 AST-GN74 VITEK® 2 AST-GN87 VITEK® 2 AST-N802 VITEK® 2 AST-GN66 VITEK® 2 AST-GN68 VITEK® 2 AST-N800 VITEK® 2 AST-N801 VITEK® 2 AST-GN77 VITEK® 2 AST-GN84 VITEK® 2 AST-GN92 VITEK® 2 AST-GN73 VITEK® 2 AST-GN79 VITEK® 2 AST-GN69 VITEK® 2 AST-GN95 VITEK® 2 AST-GN67 VITEK® 2 AST-GN81 VITEK® 2 AST-GN70 VITEK® 2 AST-GN93 VITEK® 2 AST-GN99 VITEK® 2 AST-GN76 VITEK® 2 AST-GN91 VITEK® 2 AST-GN90 VITEK® 2 AST-GN83 VITEK® 2 AST-GN82 VITEK® 2 AST-GN80 VITEK® 2 AST-YS09 BACT/ALERT PF PLUS CULTURE BOTTLE BACT/ALERT PF PLUS BacT/ALERT® PF PLUS VITEK® 2 AST-N800 VITEK® 2 AST-N801 VITEK® 2 AST-N802 VITEK® 2 AST-GN99 VITEK® 2 AST-GN95 VITEK® 2 AST-XN15 VITEK® 2 AST-ST01 VITEK® 2 AST-ST02 VITEK® 2 AST-XN09 VITEK® 2 AST-XN15 VITEK® 2 AST-N800 VITEK® 2 AST-GN14 VITEK® 2 ID NH VITEK® 2 AST-XN15 VITEK® 2 AST-N801 VITEK® 2 AST-YS09 VITEK® 2 AST-GP78 VITEK® 2 AST-GP71 VITEK® 2 AST-GP72 VITEK® 2 AST-GP67 VITEK® 2 AST-N800 VITEK® 2 AST-N801 VITEK® 2 AST-N802 VITEK® 2 AST-XN08 VITEK® 2 AST-N800 VITEK® 2 AST-XN15 VITEK® 2 AST-XN09 BACT/ALERT FA PLUS (PLASTIC) BACT/ALERT® FA PLUS VITEK® 2 ID GN Thermo Scientific Disposable Centrifuge Tube VITEK® 2 AST-ST02 VITEK® 2 AST-ST01 VITEK® 2 AST-ST01 VITEK® 2 AST-ST02 VITEK® 2 AST-YS09 VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-YS09 VITEK® 2 AST-GP74 VITEK® 2 AST-N801 VITEK® 2 AST-N802 VITEK® 2 AST-ST01 VITEK® 2 AST-GP68 VITEK® 2 AST-GP74 VITEK® 2 AST-GP78 VITEK® 2 AST-GP67 VITEK® 2 AST-GP71 VITEK® 2 AST-GP75 BACT/ALERT SA CULTURE BOTTLE BACT/ALERT SA (PLASTIC) BACT/ALERT SA (PLASTIC) 100 BTLS VITEK® 2 AST-ST02 VITEK® 2 AST-ST01 VITEK® 2 AST-XN15 AST TEST KIT CARDS VITEK® 2 AST-ST01 VITEK® 2 AST-ST02 BACT/ALERT FN PLUS (PLASTIC) BACT/ALERT® FN PLUS VITEK® 2 AST-GN91 VITEK® 2 AST-GN81 VITEK® 2 AST-GN70 VITEK® 2 AST-GN48 VITEK® 2 AST-GN82 VITEK® 2 AST-GN75 VITEK® 2 AST-GN99 VITEK® 2 AST-GN95 VITEK® 2 AST-GN76 VITEK® 2 AST-GN80 VITEK® 2 AST-GN66 VITEK® 2 AST-GN74 VITEK® 2 AST-N802 VITEK® 2 AST-GN67 VITEK® 2 AST-GN90 VITEK® 2 AST-GN68 VITEK® 2 AST-GN69 VITEK® 2 AST-GN73 VITEK® 2 AST-N800 VITEK® 2 AST-GN84 VITEK® 2 AST-GN86 VITEK® 2 AST-GN49 VITEK® 2 AST-GN87 VITEK® 2 AST-GN77 VITEK® 2 AST-N801 VITEK® 2 AST-GN92 VITEK® 2 AST-ST02 VITEK® 2 AST-ST01 VITEK® 2 AST-ST02 VITEK® 2 AST-ST01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2018-05-23
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2021-03-26
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2024-04-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LQL	Gram Positive Identification Panel	Microbiology	Class 1	866.2660	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2021-03-26
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2018-05-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2021-03-26
JSP	Kit, Anaerobic Identification	Microbiology	Class 1	866.2660	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-03
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2023-08-04
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2018-05-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
JST	Kit, Fastidious Organisms	Microbiology	Class 1	866.2660	2021-03-26
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2021-03-26
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2018-05-23
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2021-03-26
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2026-04-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2021-10-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2023-08-04
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2018-05-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-08-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2018-05-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-03-26

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
3019946577	UPS Supply Chain Solutions, Inc.	Fairdale, KY, US
3009171251	UPS SUPPLY CHAIN SOLUTIONS, INC.	Louisville, KY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K232967	bioMerieux, Inc.	VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)	2024-06-12
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).

Similar Registrations

Registration Number	Establishment Name	Location
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
3031977134	bioMerieux, Inc.	Morrisville, NC, US
1950204	BIOMERIEUX, INC.	HAZELWOOD, MO, US
3007502289	Laboratorios PiSA, S. A. de C.V.	Tlajomulco de Zuniga Jalisco, MX
1111096	BECTON, DICKINSON & CO.	Cockeysville, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013718871. Last updated year: 2026. Please use registration number 3013718871 when referencing this establishment in official correspondence.