FDA.reportPublic FDA data

Lp(a) Ultra

Primary DI
08058056680211
Brand
Lp(a) Ultra
Company
SENTINEL CH. SPA
Model
11504D
Catalog number
11504D
Device description
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation.For In Vitro Diagnostic use.
Published
2024-03-15
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
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFCLipoprotein, Low-Density, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211058000Lp(a) UltraSENTINEL CH. SpA2022-12-22DFC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056680211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056680211080580566802118058056680211

GMDN Terms#

Term, Definition table
TermDefinition
Lipoprotein A 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 lipoprotein A lipid in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
Device count
1
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
08058056680228Lp(a) Cal Set11522D11522D2024-03-15
08058056681744Lp(a) Control Set115220111522012024-03-15
08058056680181Ammonia Ultra 17660176602023-11-22
08058056680617Lipase Color Liquid17401B17401B2017-01-16
08058056681911CRP Ultra (MP)1156461156462018-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336237380Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237397Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237403Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDDFC2022-10-05
00380740170165ARCHITECTABBOTT IRELANDDFC2022-03-16
00380740170158AlinityABBOTT IRELANDDFC2021-05-19
00811727015921Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00811727016225Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00380740175146ARCHITECTAbbott GmbHDFC2020-12-15
07613336140833Tina-quant Lipoprotein (a) Gen.2Roche Diagnostics GmbHDFC2020-03-16
07613336133538Tina-quant Apolipoprotein B ver.2Roche Diagnostics GmbHDFC2020-03-05
00380740156435ARCHITECTABBOTT LABORATORIESDFC2020-03-03
00380740154509AlinityAbbott GmbHDFC2019-09-09
00380740153847AlinityABBOTT LABORATORIESDFC2019-05-10
00817302022308CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00817302022315CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00630414595559Atellica CH Lp(a)Siemens Healthcare Diagnostics Inc.DFC2017-12-21
00817439021069MedTest Dx, Inc. Lp (a)Medtest Dx, Inc.DFC2016-09-27
00817439021090MedTest DX Lipoprotein (a) Calibrator for the BS480Medtest Dx, Inc.DFC2016-09-27
05055273204421Lp (a)RANDOX LABORATORIES LIMITEDDFC2016-09-26
05051700016841Lipoprotein (a) Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDFC2016-09-24
05055273204384Lp (a)RANDOX LABORATORIES LIMITEDDFC2016-09-24
00842768007552N Latex Lp(a) ReagentSiemens Healthcare Diagnostics Products GmbHDFC2016-09-24
05391516743938Trinity BiotechCLARK LABORATORIES, INC.DFC2016-09-23
04015630917730Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630917754Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630928668Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630929962Tinaquant Lipoprotein a Gen.2Roche Diagnostics GmbHDFC2016-09-20
04015630930234Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630930586Tinaquant Lipoprotein a Gen.2Roche Diagnostics GmbHDFC2016-09-20