FDA.reportPublic FDA data

Alinity

Primary DI
00380740153847
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
01R1421
Catalog number
01R1421
Device description
Alinity c Lp(a) Reagent Kit 200 Tests
Published
2019-05-10
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
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
K050487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050487000QUANTIA LA(A)Biokit, S.A.2005-04-26DFC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740153847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740153847003807401538473807401538470380740153847

GMDN Terms#

Term, Definition table
TermDefinition
Lipoprotein A IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079226220
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
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

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
08058056680211Lp(a) UltraSENTINEL CH. SPADFC2024-03-15
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
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