FDA.reportPublic FDA data

Lipase NG

Primary DI
08058056681782
Brand
Lipase NG
Company
SENTINEL CH. SPA
Model
B82715
Catalog number
B82715
Device description
The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.
Published
2016-08-07
Public version status
Update
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
08058056681782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056681782080580566817828058056681782

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume150Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
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
08058056681232CeruloplasminA26842A268422016-07-29
08058056685391Cystatin C Calibrators06T320106T32012025-09-16
08058056685407Cystatin C Controls06T321006T32102025-09-16
08058056685414Cystatin C06T322006T32202025-09-16
08058056685421Cystatin C06T323006T32302025-09-16
08058056681973Albumin BCP (6x20 mL)C22855C228552020-02-24
08058056681980Albumin BCP (6x50 mL)C22856C228562020-02-24
08058056685438ARCHITECT c ACE Assay File6U82-1A6U82-1A2025-03-10
08058056685445Alinity c ACE Assay File06U86-1A06U86-1A2025-03-10
08058056685285ACE Calibrator06U820106U82012025-01-27
08058056685292ACE Control06U821006U82102025-01-27
08058056685308ACE Reagent06U822506U82252025-01-27
08058056685315ACE Calibrator06U860106U86012025-01-27
08058056685322ACE Control06U861006U86102025-01-27
08058056685339ACE Reagent06U862506U86252025-01-27
08058056680211Lp(a) Ultra11504D11504D2024-03-15
08058056680228Lp(a) Cal Set11522D11522D2024-03-15
08058056681744Lp(a) Control Set115220111522012024-03-15
08058056680181Ammonia Ultra 17660176602023-11-22
08058056680617Lipase Color Liquid17401B17401B2017-01-16

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
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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