FDA.reportPublic FDA data

APCI-8050 SET

Primary DI
04540217400713
Brand
APCI-8050 SET
Company
SHIMADZU CORPORATION
Model
225-19601-55
Published
2022-05-20
Public version status
Update
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
04540217400713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04540217400713045402174007134540217400713

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690558747
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
04540217040872SONIALVISION G4503-78000-512019-08-14
04540217040889SONIALVISION G4503-78000-522019-08-14
04540217040896SONIALVISION G4503-78000-532019-08-14
04540217041022SONIALVISION G4566-10000-412019-08-14
04540217041039SONIALVISION G4566-10000-422019-08-14
04540217041046SONIALVISION G4566-10000-432019-08-14
04540217041053SONIALVISION G4566-10000-462019-08-14
04540217041060SONIALVISION G4566-10000-472019-08-14
04540217059539R-20J563-55050-312020-02-21
04540217059553Trinias503-79831-432019-05-31
04540217059607Trinias503-79823-432019-05-31
045402170607880.7/1.2JG326 D-265582-24825-422019-07-23
045402170608250.4/0.7JG326 D-265582-24838-112019-07-23
04540217061006Trinias503-79830-432019-05-31
04540217061099Trinias503-79832-432019-05-31
04540217061136Trinias503-79840-432019-05-31
045402170614260.7/1.2JG326 D-265582-24825-042019-07-23
045402170618840.6/1.2P324DK-85582-24486-502020-02-21
045402170618910.6/1.2P324DK-85582-24486-572020-02-21
045402170620340.6/1.2P13DK-85582-24476-502020-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816776021473XevoWATERS TECHNOLOGIES CORPORATIONDOP2026-07-07
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
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
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