FDA.reportPublic FDA data

Alinity

Primary DI
00380740186241
Brand
Alinity
Company
Abbott GmbH
Model
04T991A
Catalog number
04T991A
Device description
Alinity c LDH2 Assay File
Published
2025-12-19
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
JJEAnalyzer, chemistry (photometric, discrete), for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740186241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740186241003807401862413807401862410380740186241

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
315786293
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740186173Alinity04T971A04T971A2026-10-15
00380740186180Alinity04T973A04T973A2026-10-15
00380740186197Alinity04T975A04T975A2026-10-15
00380740150662Alinity09P562009P56202019-06-27
00380740150679Alinity09P572009P57202019-06-27
00380740150693Alinity09P632009P63202019-07-08
00380740153922Alinity09P622009P62202019-12-24
00380740199265Alinity06T790106T79012026-09-04
00380740199272Alinity06T791006T79102026-09-04
00380740208899Alinity06T792106T79212026-09-04
00380740208905Alinity06T793106T79312026-09-04
00380740223724Alinity06T793A06T793A2026-09-04
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740186173AlinityAbbott GmbHJJE2026-10-15
00380740186180AlinityAbbott GmbHJJE2026-10-15
00380740186197AlinityAbbott GmbHJJE2026-10-15
00380740225742ARCHITECTABBOTT LABORATORIESJJE2026-10-14
00380740225759ARCHITECTABBOTT LABORATORIESJJE2026-10-14
00380740223724AlinityAbbott GmbHJJE2026-09-04
00380740225575ARCHITECTABBOTT LABORATORIESJJE2026-08-22
00810053950074NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950104NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950111NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950135NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950456NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950463NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950494NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024333NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024982NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025354NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025378NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027969NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29