FDA.reportPublic FDA data

AlinIQ

Primary DI
00380740212575
Brand
AlinIQ
Company
ABBOTT SRL
Model
03R8965
Catalog number
03R8965
Device description
AlinIQ AMS
Published
2024-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQPCalculator/data processing module, for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740212575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740212575003807402125753807402125750380740212575

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
430747238
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740189914AlinIQ03R89-4803R89482020-07-14
00380740145125AlinIQ03R89-2403R89242019-12-20
00380740189907AlinIQ03R89-4703R89472020-03-16
00380740145118AlinIQ03R89-2303R89232018-10-12
00380740158255AlinIQ03R89-2103R89212018-01-26
00380740216658AlinIQ03R896703R89672025-04-30
00380740202736AlinIQ03R896303R89632022-12-30
00380740200169AlinIQ03R89-6203R89622022-04-14
00380740196875AlinIQ03R895903R89592021-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374453SoftBiochemistrySCC SOFT COMPUTERJQP2026-07-14
00810142374460SoftCytogeneticsSCC SOFT COMPUTERJQP2026-07-14
00810142374477SoftPathDxSCC SOFT COMPUTERJQP2026-07-14
00810142374484SoftFlowCytometrySCC SOFT COMPUTERJQP2026-07-14
00810142374491SoftHLASCC SOFT COMPUTERJQP2026-07-14
00810142374507SoftMolecularSCC SOFT COMPUTERJQP2026-07-14
00810142374514SoftGenomicsSCC SOFT COMPUTERJQP2026-07-14
00810142374521SoftTrackSCC SOFT COMPUTERJQP2026-07-14
00810142374279SoftBiobankSCC SOFT COMPUTERJQP2026-07-07
00810142373814SoftTotalQCSCC SOFT COMPUTERJQP2026-07-03
00810142373791SoftGenePortalSCC SOFT COMPUTERJQP2026-06-13
00810142373869SoftBiochemistrySCC SOFT COMPUTERJQP2026-06-10
00810142373876SoftCytogeneticsSCC SOFT COMPUTERJQP2026-06-10
00810142373883SoftPathDxSCC SOFT COMPUTERJQP2026-06-10
00810142373890SoftFlowCytometrySCC SOFT COMPUTERJQP2026-06-10
00810142373906SoftHLASCC SOFT COMPUTERJQP2026-06-10
00810142373920SoftMolecularSCC SOFT COMPUTERJQP2026-06-10
00810142373937SoftGenomicsSCC SOFT COMPUTERJQP2026-06-10
00810142373944SoftTrackSCC SOFT COMPUTERJQP2026-06-10
00810142373012SoftPathSCC SOFT COMPUTERJQP2026-05-29
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28