FDA.reportPublic FDA data

microINR® Expert Kit

Primary DI
08436540291141
Brand
microINR® Expert Kit
Company
ILINE MICROSYSTEMS SL
Model
KTQ0001AD
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GJSTest, Time, Prothrombin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436540291158Direct MarkingGS10
08436540291141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436540291158084365402911588436540291158
08436540291141084365402911418436540291141

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, home-use, battery-poweredAn exclusively battery-powered instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.

Regulatory Flags#

DUNS number
460067955
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436540290717microINR ® CHIPS CHC0025AD2021-05-28
08436540290816microINR ® MeterKTC0001AD2021-05-28
08436540291134microINR ® Link KitKTL0001AD2024-08-02
08436540290915microINR ® Link KitKTL0001AD2024-08-02
08436540290908microINR ® Link KitKTE0001AD2024-04-01
08436540290700microINR ® CHIPS CHC0025AD2021-05-28
08436540290694microINR ® MeterKTC0001AD2021-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09360136000079 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000086 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
08436540291134microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
08436540290915microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
00850053916205IDG/SanzayIDG/SANZAY CorporationGJS2024-07-03
08436540290908microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-04-01
00630414639871Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639888Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639963Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414640006Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019593Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019609Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768018749Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019586Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00850053916182IDG/SanzayIDG/SANZAY CorporationGJS2024-01-12
00054749004782i-STAT PTplus CartridgeAbbott Point of Care Inc.GJS2024-01-10
00054749004843i-STAT PTplus Control Level 1Abbott Point of Care Inc.GJS2024-01-10
00054749004850i-STAT PTplus Control Level2Abbott Point of Care Inc.GJS2024-01-10
00365702702356CoaguChek VantusRoche Diagnostics GmbHGJS2023-12-01
00850040656022Assure PT Care PT/INR Monitoring System COAGUSENSE INC.GJS2023-04-06
00850040656039Assure PT Care Test Strip KitCOAGUSENSE INC.GJS2023-04-06
00860007370861Coag-senseCOAGUSENSE INC.GJS2021-09-30
00860007370878Coag-senseCOAGUSENSE INC.GJS2021-09-30
00861900000398Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
10861900000395Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
08436540290816microINR ® MeterILINE MICROSYSTEMS SLGJS2021-05-28
08436540290700microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
08436540290694microINR ® MeterILINE MICROSYSTEMS SLGJS2021-05-28