FDA.reportPublic FDA data

Alinity

Primary DI
00380740204037
Brand
Alinity
Company
ABBOTT IRELAND
Model
04U0001
Catalog number
04U0001
Device description
Lipase2 Calibrator
Published
2025-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00380740204037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740204037003807402040373807402040370380740204037

GMDN Terms#

Term, Definition table
TermDefinition
Lipase IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipase in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius-20 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15
00380740155889ARCHITECT04T343004T34302024-08-15

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
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
07613336121399Lipase colorimetric assayRoche Diagnostics GmbHCHI2020-03-05