Home GUDID 10837461002192 iQ®200
Primary DI 10837461002192
Brand iQ®200
Company IRIS INTERNATIONAL, INC.
Model iQ® Lamina™ Cradle
Catalog number 800-3105
Device description iQ® Lamina™ Cradle
Published 2016-09-07
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name LKM Counter, Urine Particle
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKM Counter, Urine Particle Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10837461002192 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10837461002192 10837461002192
GMDN Terms# Term, Definition table Term Definition Urine analyser IVD, laboratory An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.
Regulatory Flags# DUNS number 098240690 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10837461001973 IRISpec CA/CB Twinset 800-7211 2016-09-07 10837461002116 iQ®200 iQ® Lamina™ Case of 4 x 7 L 800-3102 2016-09-07 10837461008002 AX-4280 Specific Gravity Calibrator Set (NA) 800-3517 2016-09-07 10873037000766 StatSpin X00-003808-001 X00-003808-001 2016-09-24 10837461002529 iChem iChem®10SG Urine Chemistry Strips 800-7005 2016-09-07 10837461002536 vChem® vChem®10 SG Urine Chemistry Strips 800-7007 2016-09-07
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00015482188627 AUTION EYE™ AI-4510 Analyzer ARKRAY USA, INC. LKM 2024-12-02 04987562440139 Fully Automated Urine Particle Analyzer UF-5000 SYSMEX CORPORATION LKM 2018-05-31 10837461001256 iQ200 BECKMAN COULTER IRELAND INC. LKM 2016-09-07 10837461001300 iQ200 BECKMAN COULTER IRELAND INC. LKM 2016-09-07 10837461001317 iQ200 BECKMAN COULTER IRELAND INC. LKM 2016-09-07 10837461001355 iQ200 BECKMAN COULTER IRELAND INC. LKM 2016-09-07 04987562408542 Fully Automated Urine Particle Analyzer UF-1000i SYSMEX CORPORATION LKM 2016-08-04 00664369000639 Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software Sysmex America, Inc. LKM 2016-08-04