AX-4280 800-3517

GUDID 10837461008002

AX-4280 Specific Gravity Calibrator Set

IRIS INTERNATIONAL, INC.

Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control

• Primary Device ID: 10837461008002
• NIH Device Record Key: 7fe30413-8b94-4b3b-ab49-8539054f2c2c
• Commercial Distribution Discontinuation: 2021-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AX-4280
• Version Model Number: Specific Gravity Calibrator Set (NA)
• Catalog Number: 800-3517
• Company DUNS: 098240690
• Company Name: IRIS INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10837461008002 [Primary]

FDA Product Code

• KQO: Automated Urinalysis System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-08
• Device Publish Date: 2016-09-07

Devices Manufactured by IRIS INTERNATIONAL, INC.

• 10837461001973 - IRISpec: 2023-09-08 IRISpec CA/CB Twinset
• 10837461002116 - iQ®200: 2023-09-08
• 10837461008002 - AX-4280: 2023-09-08AX-4280 Specific Gravity Calibrator Set
• 10837461008002 - AX-4280: 2023-09-08 AX-4280 Specific Gravity Calibrator Set
• 10873037000766 - StatSpin: 2023-09-08 CritSpin Digital Reader
• 10837461001256 - iQ200: 2022-09-16 "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA
• 10837461001300 - iQ200: 2022-09-16 "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA) "iQ200 Select 2008 Tested; 800-3051 iQ®200 Select
• 10837461001317 - iQ200: 2022-09-16 "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)" "iQ200 Elite 2008 Tested; 800-3052 iQ®200 Elite Pro (NA); 800-3049 I
• 10837461001355 - iQ200: 2022-09-16 "iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA); 800-7714 IRICELL 2000 Plus (NA)"