FDA.reportPublic FDA data

LIPASE (LPS)

Primary DI
05055273209136
Brand
LIPASE (LPS)
Company
RANDOX LABORATORIES LIMITED
Model
LI8050
Published
2019-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
05055273209136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273209136050552732091365055273209136

GMDN Terms#

Term, Definition table
TermDefinition
Lipase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of lipase in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
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
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

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
10758750004683VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CHI2020-04-18
10758750009510VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CHI2020-04-18