FDA.reportPublic FDA data

FCV-32AH CL

Primary DI
04540217420353
Brand
FCV-32AH CL
Company
SHIMADZU CORPORATION
Model
228-45166-55
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
KIEApparatus, High Pressure Liquid Chromatography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIEApparatus, High Pressure Liquid ChromatographyClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04540217420353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04540217420353045402174203534540217420353

GMDN Terms#

Term, Definition table
TermDefinition
High performance liquid chromatography analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument designed for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. Chemical components are separated by passing pressurized liquid through a narrow column to allow the various components to separate based on their chemical/physical properties while interacting with column filling. As the substances exit the column they are detected and identified electronically or spectrometrically. The device is used for the identification of complex substances such as drugs and hormones. It operates with reduced technician involvement and automation of some procedural steps.

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
00842365100519Jasper HPLC SystemAB SCIEX (MANUFACTURING)KIE2022-09-28
057005740072251260 Infinity II LC System Clinical EditionAGILENT TECHNOLOGIES, INC.KIE2022-08-15
04540217420070CBM-20A CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420131SIL-20ACXR CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420186FCV-32AH CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420261LC-20ADXR CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420278LC-30AD CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420346CTO-30A CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420377SPD-M30A CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420476LC-30AD CLSHIMADZU CORPORATIONKIE2022-05-20
04540217420520CBM-40 CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420537DGU-405 CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420544LC-40D X3 CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420551LC-40B X3 CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420568LC-40D XR CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420575SIL-40C X3 CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420582SIL-40C XR CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420599PLATE CHANGER CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420605CTO-40C CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420612FCV-S CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420629SPD-40 CLSHIMADZU CORPORATIONKIE2021-01-15
04540217420056CTO-20AC CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420179LC-30AD CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420193RESERVOIR SWITCHING VALVE KIT FOR LC-30AD CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420216SPD-M30A CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420247CBM-20A CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420308SIL-20ACXR CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420315SIL-30AC CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420384SPD-20AV CLSHIMADZU CORPORATIONKIE2020-10-28
04540217420391CTO-20AC CLSHIMADZU CORPORATIONKIE2020-10-28