FDA.reportPublic FDA data

Xevo

Primary DI
00816776020254
Brand
Xevo
Company
WATERS TECHNOLOGIES CORPORATION
Model
186009782IVD
Catalog number
186009782IVD
Published
2023-04-06
Public version status
New
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
00816776020254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816776020254008167760202548167760202540816776020254

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

Contacts#

Phone, Email table
PhoneEmail
1-800-252-4752customerservice@waters.com

Regulatory Flags#

DUNS number
107186004
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
00816776020551MassTrak186010565IVD186010564IVD2023-12-05
00816776020247MassTrak186010560IVD186010560IVD2022-12-22
00816776020544MassTrak186010563IVD186010563IVD2023-12-05
00816776020568MassTrak186010565IVD186010565IVD2023-12-05
00816776020575MassTrak186010566IVD186010566IVD2023-12-05
00816776020582MassTrak186010568IVD186010568IVD2023-12-05
00816776020599MassTrak186010567IVD186010567IVD2023-12-05
00816776020421MassTrak186009311IVD186009311IVD2021-10-25
00816776020438MassTrak186009312IVD186009312IVD2021-10-25
00816776020445Acquity186015082IVD186015082IVD2022-03-01
00816776020452Acquity186015088IVD186015088IVD2022-03-01
00816776020469Acquity186015087IVD186015087IVD2022-03-01
00816776020476Acquity186015014IVD186015014IVD2022-03-01
00816776020315Acquity725000662IVD725000662IVD2021-10-06
00816776020346Xevo186008453IVD186008453IVD2021-10-06
00816776020179Xevo186007833IVD186007833IVD2021-10-05
00816776020087Acquity186015007IVD186015007IVD2021-10-04
00816776020094Acquity186015010IVD186015010IVD2021-10-04
00816776020100Acquity186015020IVD186015020IVD2021-10-04
00816776020117Acquity186015043IVD186015043IVD2021-10-04

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
00842365102568Triple Quad™ 4500MDAB SCIEX (MANUFACTURING)DOP2024-06-14
05061024690009SerconSERCON LIMITEDDOP2023-08-30
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