FDA.reportPublic FDA data

VITROS

Primary DI
10758750004683
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8297749
Catalog number
8297749
Device description
VITROS Chemistry Products LIPA Slides
Published
2020-04-18
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
CHILIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHILipase-Esterase, Enzymatic, Photometric, LipaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750004683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000468310758750004683

GMDN Terms#

Term, Definition table
TermDefinition
Lipase IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of lipase in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740180713AlinityABBOTT IRELANDCHI2025-10-24
00380740180720ARCHITECTABBOTT IRELANDCHI2025-10-24
00380740204020ARCHITECTABBOTT IRELANDCHI2025-10-24
00380740204037AlinityABBOTT IRELANDCHI2025-10-24
06971674866916BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866923BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866930BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866947BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866954BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866961BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866978BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
05055273204247LIPASE (LPS)RANDOX LABORATORIES LIMITEDCHI2022-10-04
00817302024135CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
00817302024357CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT CC621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
00817302024470CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT DT621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
00817302024616CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT ST621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
00630414292748Dimension Lipase (LIP) Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.CHI2021-11-11
00630414306247Dimension Lipase (LIP) Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.CHI2021-11-11
00630414292762Dimenison Vista Lipase Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.CHI2021-11-05
00630414306254Dimenison Vista Lipase Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.CHI2021-11-05
04015630926985Lipase colorimetric assayRoche Diagnostics GmbHCHI2021-02-08
04015630917570Lipase colorimetric assayRoche Diagnostics GmbHCHI2021-01-18
04015630934812Lipase colorimetricRoche Diagnostics GmbHCHI2021-01-18
00630414482446ADVIA® Chemistry LIP Lipase ReagentsSiemens Healthcare Diagnostics Inc.CHI2020-09-24
00630414596358Atellica CH LipSiemens Healthcare Diagnostics Inc.CHI2020-09-24
00842768020223Dimension Vista® Flex® reagent cartridge LIPLSiemens Healthcare Diagnostics Inc.CHI2020-09-24
00842768025532Dimension® Flex® reagent cartridge LIPLSiemens Healthcare Diagnostics Inc.CHI2020-09-24
03610230007105Yumizen C1200 LipaseHORIBA ABX SASCHI2020-08-28
10758750009510VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CHI2020-04-18
07613336121399Lipase colorimetric assayRoche Diagnostics GmbHCHI2020-03-05