AUTION™ MAX AX-4030 Analyzer

GUDID 00015482145057

Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results.  Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.

ARKRAY USA, INC.

Urine analyser IVD, laboratory

• Primary Device ID: 00015482145057
• NIH Device Record Key: 9093edc2-2055-49fe-92fd-9ad76e800260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTION™ MAX AX-4030 Analyzer
• Version Model Number: 14505
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx
• Phone: +1(999)999-9999
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482145057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093098

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: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2016-09-23

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