AX-4280 800-3517

GUDID 10837461008002

AX-4280 Specific Gravity Calibrator Set

IRIS INTERNATIONAL, INC.

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)"