FDA.reportPublic FDA data

Alinity

Primary DI
00380740215712
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
03R6584
Catalog number
03R6584
Device description
Alinity i Processing Module, refurbished
Published
2025-10-08
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
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CFRHEXOKINASE, GLUCOSE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
JGSELECTRODE, ION SPECIFIC, SODIUM
JJEAnalyzer, chemistry (photometric, discrete), for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CFRHexokinase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740215712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740215712003807402157123807402157120380740215712

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.

Contacts#

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

Regulatory Flags#

DUNS number
117245596
Device count
1
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
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

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