Aution™ Hybrid AU-4050 Chemical Analyzer

GUDID 00015482146030

he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathological Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

ARKRAY USA, INC.

Flow cytometry analyser IVD

• Primary Device ID: 00015482146030
• NIH Device Record Key: 2d37ce6d-7c18-4e1d-9463-0ed1217fab8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aution™ Hybrid AU-4050 Chemical Analyzer
• Version Model Number: 14603
• 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: 9999999999
• Email: xxx@xxx.xxx
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• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
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• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
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• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482146030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121456

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: 2017-02-06

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