FDA.reportPublic FDA data

Yumizen C1200 Lipase

Primary DI
03610230007105
Brand
Yumizen C1200 Lipase
Company
HORIBA ABX SAS
Model
1300023858
Published
2020-08-28
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
03610230007105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230007105036102300071053610230007105

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
273647420
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610230006849Yumizen C1200 Amylase13000238312020-08-31
03610230004883ABX PENTRA IMMUNO II CONTROL L/H12200016222016-08-23
03610230004623ABX CLEANER (0.5L)12109030112016-08-16
03610230009932ABX Micros 6013001465762026-01-23
03610230009444Yumizen H250013001021472024-11-29
03610230009451Yumizen H250013001021482024-11-29
03610230005774ABX PENTRA MICRO-ALB CAL12200019662016-09-05
03610230005781ABX PENTRA MICRO ALB CONTROL L/H12200019672016-08-16
03610230008232ABX Pentra Micro ALB 2 Cal13000325652017-07-07
03610230005187ABX PENTRA ALBUMIN CP12200016642016-08-23
03610230005767ABX PENTRA MICRO ALBUMIN CP12200019652016-08-16
03610230008225ABX Pentra Micro ALBUMIN 2 CP13000325632017-06-27
03610230007235Yumizen C1200 Albumin U/CSF13000238712020-09-14
03610230007464Yumizen C1200 Micro Alb U/CSF Cal Normal 1300023894 2020-09-07
03610230007891Yumizen C1200 U/CSF L1 Micro Alb Control 1300023948 2020-09-07
03610230007914Yumizen C1200 U/CSF L2 Micro Alb Control 1300023949 2020-09-07
03610230006825Yumizen C1200 Albumin13000237992020-05-06
03610230008966Yumizen P800013000333272025-07-07
03610230009611ABX Minocal530010030053001003002024-09-27
03610230008584BFTROL13000394052024-09-26

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00380740204037AlinityABBOTT IRELANDCHI2025-10-24
06971674866916BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
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06971674866954BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866961BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866978BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
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00817302024616CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT ST621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
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00842768020223Dimension Vista® Flex® reagent cartridge LIPLSiemens Healthcare Diagnostics Inc.CHI2020-09-24
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10758750004683VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CHI2020-04-18
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