FDA.reportPublic FDA data

AX-4280

Primary DI
10837461008002
Brand
AX-4280
Company
IRIS INTERNATIONAL, INC.
Model
Specific Gravity Calibrator Set (NA)
Catalog number
800-3517
Device description
AX-4280 Specific Gravity Calibrator Set
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
CodeName
KQOAutomated Urinalysis System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQOAutomated Urinalysis SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10837461008002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1083746100800210837461008002

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098240690
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10837461001973IRISpecCA/CB Twinset800-72112016-09-07
10837461002116iQ®200 iQ® Lamina™ Case of 4 x 7 L800-31022016-09-07
10873037000766StatSpinX00-003808-001X00-003808-0012016-09-24
10837461002192iQ®200 iQ® Lamina™ Cradle800-31052016-09-07
10837461002529iChemiChem®10SG Urine Chemistry Strips800-70052016-09-07
10837461002536vChem®vChem®10 SG Urine Chemistry Strips800-70072016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-04-16
00854080008612SciteckSciteck Diagnostics, Inc.KQO2026-04-07
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.KQO2025-09-18
04987486005292Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
00015482117344AUTION™ Sticks 9EB - Test StripsARKRAY USA, INC.KQO2024-12-02
00015482181550AUTION EYE™ Sheath Solution - 10L BottleARKRAY USA, INC.KQO2024-12-02
00015482181574AUTION EYE™ Control Solution H/LARKRAY USA, INC.KQO2024-12-02
00015482181598AUTION EYE™ Calibrator Focus/CalibratorARKRAY USA, INC.KQO2024-12-02
14987486005299Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSKQO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-04
20682607200508MISSION U500 URINE ANALYZERAcon Laboratories, Inc.KQO2024-03-08
20682607200515MISSION U500 URINE ANALYZERAcon Laboratories, Inc.KQO2024-03-08
10722066004408Rapid ResponseBTNX IncKQO2023-10-30
10722066004415Rapid ResponseBTNX IncKQO2023-10-30
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.KQO2023-06-08
17290017272471Minuteful - kidney testHEALTHY.IO LTDKQO2022-11-01
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.KQO2020-09-30
10885380175596CARDINAL HEALTHCardinal Health 200, LLCKQO2020-07-07
20885380175548CARDINAL HEALTHCardinal Health 200, LLCKQO2020-06-30
20885380175562CARDINAL HEALTHCardinal Health 200, LLCKQO2020-06-30
08800068200020My YodocS-CONNECT CO.,LTDKQO2020-04-10