FDA.reportPublic FDA data

K6460 Triple Quadrupole MS – AJS

Primary DI
05700574007300
Brand
K6460 Triple Quadrupole MS – AJS
Company
AGILENT TECHNOLOGIES, INC.
Model
K6460 Triple Quadrupole MS – AJS
Device description
K6460 Triple Quadrupole MS – AJS
Published
2022-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DOPMASS SPECTROMETER, CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DOPMass Spectrometer, Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700574007300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700574007300057005740073005700574007300

GMDN Terms#

Term, Definition table
TermDefinition
Liquid chromatography/mass spectrometry (LC/MS) analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument designed for the qualitative and/or quantitative in vitro determination of the chemical composition of a clinical specimen. The sample is introduced in a pressurized liquid and its compounds are separated based on their chemical/physical properties while interacting with a column filling; as the substances exit the column they are ionized and the resulting ions are separated according to mass using an electromagnetic field. The device is used for identification and quantification of complex substances (e.g., drugs, hormones). It operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-800-227-9770Global.RA@agilent.com

Regulatory Flags#

DUNS number
084963177
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700575016899PD-L1 Control SlidesT13912026-04-29
05700573001736PD-L1 Control SlidesT13912020-11-17
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1M36752026-01-21
05700571102305Mono Mo A-Hu Progesterone Receptor, Cl PgR 636M35692016-09-16
05700571107713DakoGC2062024-08-07
05700575005213MLH1 IHC pharmDx (Dako Omnis)GE0792025-08-27
05700575005220MSH2 IHC pharmDx (Dako Omnis)GE0852025-08-27
05700575005237MSH6 IHC pharmDx (Dako Omnis)GE0862025-08-27
05700575005244PMS2 IHC pharmDx (Dako Omnis)GE0872025-08-27
05700575005251MMR Negative Control Reagent, Mouse (Dako Omnis)GE1012025-08-27
05700575005268MMR Negative Control Reagent, Rabbit (Dako Omnis)GE1022025-08-27
05700571102022Mono Mo A-Adrenocorticotropin (ACTH) Cl 02A3M35012020-09-17
05700571102053Mono Mo A-Hu Follicle Stimulating Hormone (FSH) Cl C10M35042020-09-17
05700571102190Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1M35392020-09-17
05700571102503Mono Mo A-Hu Tyrosinase Cl T311M36232020-09-17
05700571101933Mono Mo A-Thrombomodulin Cl 1009M06172020-09-17
05700571102039Mono Mo A-Hu Luteinizing Hormone (LH) Cl C93M35022020-09-17
05700571101995Mono Mo A-Hu Muscle Actin Cl HHF35M06352020-09-17
05700571105146Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294M35682016-09-16
05700571102046Mono Mo A-Hu Thyroid Stimulating Hormone (TSH) Cl 0042M35032020-09-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06438147384709Qsight 225 MD Screening SystemWallac OyDOP2023-03-29
00842365100533Citrine Triple Quad™ MS/MSAB SCIEX (MANUFACTURING)DOP2022-09-28
00842365100540Citrine QTRAP MS/MSAB SCIEX (MANUFACTURING)DOP2022-09-28
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00842365102063AB SCIEX QTRAP® 4500MDAB SCIEX (MANUFACTURING)DOP2022-09-28
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00816776020346XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-06
00816776020179XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-05
00816776020155XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-04
00816776020162XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-04
04540217400621LCMS-8050 CLSHIMADZU CORPORATIONDOP2020-10-28
04540217400645LCMS-8060 CLSHIMADZU CORPORATIONDOP2020-10-28
04540217400799LCMS-8040 CLSHIMADZU CORPORATIONDOP2020-10-28
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