FDA.reportPublic FDA data

Triple Quad™ 4500MD

Primary DI
00842365102568
Brand
Triple Quad™ 4500MD
Company
AB SCIEX (MANUFACTURING)
Model
5312404
Published
2024-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00842365102568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842365102568008423651025688423651025680842365102568

GMDN Terms#

Term, Definition table
TermDefinition
Mass spectrometry analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the chemical composition of a clinical specimen by ionizing the specimen and separating the resulting ions according to mass using an electrical and magnetic field.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595281292
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
00842365100519Jasper HPLC System50570292022-09-28
00842365100533Citrine Triple Quad™ MS/MS50508032022-09-28
00842365100540Citrine QTRAP MS/MS50508072022-09-28
00842365102049AB SCIEX Triple Quad™ 4500MD50617242022-09-28
00842365102063AB SCIEX QTRAP® 4500MD50617222022-09-28
00842365100038TopazTM System 50504122017-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336231357cobas i 601 SBLRoche Diagnostics GmbHDOP2025-08-08
07613336231388cobas pro i 601 BLRoche Diagnostics GmbHDOP2025-08-08
07613336231364cobas i 601Roche Diagnostics GmbHDOP2025-07-31
05061024690009SerconSERCON LIMITEDDOP2023-08-30
00816776020254XevoWATERS TECHNOLOGIES CORPORATIONDOP2023-04-06
06438147371815Qsight 210 MD Screening SystemWallac OyDOP2023-03-29
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
00842365102049AB SCIEX Triple Quad™ 4500MDAB SCIEX (MANUFACTURING)DOP2022-09-28
00842365102063AB SCIEX QTRAP® 4500MDAB SCIEX (MANUFACTURING)DOP2022-09-28
05700574007300K6460 Triple Quadrupole MS – AJSAGILENT TECHNOLOGIES, INC.DOP2022-08-15
05700574007317K6460 Triple Quadrupole MS – ESIAGILENT TECHNOLOGIES, INC.DOP2022-08-15
04540217400607LCMS-8040 CLSHIMADZU CORPORATIONDOP2022-05-20
04540217400669LCMS-8045CLSHIMADZU CORPORATIONDOP2022-05-20
04540217400713APCI-8050 SETSHIMADZU CORPORATIONDOP2022-05-20
04540217400720LCMS-8050 CLSHIMADZU CORPORATIONDOP2022-05-20
04540217400744LCMS-8060 CLSHIMADZU CORPORATIONDOP2022-05-20
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
00850010566023SpectroChip CPM Kit (2x96)AGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566030SpectroChip CPM Kit (10x96)AGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566061CalibrantAGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566009MassARRAAY DxAGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566016CPM DxAGENA BIOSCIENCE, INC.DOP2020-09-08