FDA.reportPublic FDA data

Thermo Scientific™ Sensititre™ ARIS HiQ™ System

Primary DI
05032384545872
Brand
Thermo Scientific™ Sensititre™ ARIS HiQ™ System
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
V4000
Device description
The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument.
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191914000
K191918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191914000Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific2019-11-06LRG
K191918000Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific2019-11-06LRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M578V4000PreviousHIBCC0
05032384545872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384545872050323845458725032384545872

GMDN Terms#

Term, Definition table
TermDefinition
Microorganism identification/antimicrobial-susceptibility analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production.

Contacts#

Phone, Email table
PhoneEmail
+441256694238microbiology.techsupport.uk@thermofisher.com

Regulatory Flags#

DUNS number
298203498
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384574230CMC1NJNFCMC1NJNF2026-05-06
05032384569588STP8FSTP8F2026-03-19
05032384474370SensititreGPN3F2025-04-11
05032384490813SensititreGPALL3F2025-04-11
05032384500406SensititreFDANDPF2025-04-11
05032384522941SensititreGN7F2025-04-11
05032384574384SensititreHPB22025-04-11
05032384576050SensititreARUP1MDF2025-04-11
05032384571499SensititreGPN3F2025-04-11
05032384571482SensititreGPALL3F2025-04-11
05032384571574SensititreFDANDPF2025-04-11
05032384571758SensititreGN7F2025-04-11
05032384580132SensititreHPB22025-04-11
05032384580613SensititreARUP1MDF2025-04-11
05032384551811SensititreSTP7F 2024-07-24
05032384557615SensititreMDRGN3F 2024-07-24
05032384561742SensititreGNUR5F2024-07-24
05032384571413SensititreYO3IVD2024-07-25
05032384571451SensititreYO2IVD2024-07-25
05032384571536SensititreESB1F2024-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384569588STP8FTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2026-03-19
15099590798970MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LRG2025-12-08
05032384474370SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384490813SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384500406SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384522941SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384574384SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384526147SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384539468SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384566815SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384571659SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384511013SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384512621SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384525829SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384530021SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384540020SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384548620SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384551811SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384557615SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571369SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571543SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571567SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571598SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571765SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571918SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24