FDA.reportPublic FDA data

Alinity

Primary DI
00380740154509
Brand
Alinity
Company
Abbott GmbH & Co. KG
Model
09P4720
Catalog number
09P4720
Device description
Alinity c Apolipoprotein B Reagent Kit 190 Tests
Published
2019-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740154509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740154509003807401545093807401545090380740154509

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein B (Apo B) 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 apolipoprotein B (Apo B) lipid in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
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
315786293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740138332Alinity07P603107P60312020-05-29
00380740192457Alinity06R901A06R901A2020-05-18
00380740170264Alinity09P521A09P521A2020-05-11
00380740170271Alinity09P523A09P523A2020-05-11
00380740121754Alinity08P072108P07212020-05-06
00380740121778Alinity08P073108P07312020-05-06
00380740136574Alinity08P071208P07122020-05-06
00380740146252Alinity08P070208P07022020-05-06
00380740151744Alinity09P411A09P411A2020-05-01
00380740154387Alinity08P073A08P073A2020-05-01
00380740163556ARCHITECT5P56-0205P56022020-05-02
00380740161798ARCHITECT7D79-2207D79222020-04-18
00380740161804ARCHITECT7D79-3207D79322020-04-18
00380740190361ARCHITECT08K280408K28042020-04-15
00380740190378ARCHITECT08K281308K28132020-04-15
00380740154325Alinity09P140309P14032018-07-30
00380740174965ARCHITECT6L45-2206L45222020-04-12
00380740174972ARCHITECT6L45-4206L45422020-04-12
00380740170318Alinity09P551A09P551A2020-03-27
00380740170325Alinity09P553A09P553A2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08058056680211Lp(a) UltraSENTINEL CH. SPADFC2024-03-15
00380740170165ARCHITECTABBOTT IRELANDDFC2022-03-16
00380740170158AlinityABBOTT IRELANDDFC2021-05-19
00811727015921Pointe Lp(a) ReagentPOINTE SCIENTIFIC, INC.DFC2021-01-30
00811727016225Pointe Lp(a) ReagentPOINTE SCIENTIFIC, INC.DFC2021-01-30
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
00380740153847AlinityABBOTT LABORATORIESDFC2019-05-10
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
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
05055273209198Lp (a)RANDOX LABORATORIES LIMITEDDFC2016-09-16
00816426020122K-ASSAY® Lp(a) Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCDFC2016-09-16
00816426020245K-ASSAY® Lp(a) ReagentKAMIYA BIOMEDICAL COMPANY, LLCDFC2016-09-16
00816426020962K-ASSAY® Lp(a) ControlKAMIYA BIOMEDICAL COMPANY, LLCDFC2016-09-16
00816426020979K-ASSAY® Lp(a) ControlKAMIYA BIOMEDICAL COMPANY, LLCDFC2016-09-16
00380740019723ARCHITECTABBOTT LABORATORIESDFC2016-09-09
00380740054267ARCHITECTABBOTT LABORATORIESDFC2016-09-09
00817302020137CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204CAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2016-09-01
00817302020144CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-DCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2016-09-01
00817302020151CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-DCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2016-09-01
00811727011824Pointe Scientific, Inc. Lipoprotein (a)POINTE SCIENTIFIC, INC.DFC2016-08-31
00811727011831Pointe Scientific, Inc. Lipoprotein (a)POINTE SCIENTIFIC, INC.DFC2016-08-31
15099590221171IMMAGEBeckman Coulter, Inc.DFC2016-08-24