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 Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD 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
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• 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

Devices Manufactured by ARKRAY USA, INC.

• 00015482183103 - SPOTCHEM™ EZ Analyzer: 2024-05-31 Dry Chemistry Analyzer IVD, semi-automated
• 00015482771010 - SPOTCHEM™ II Glucose: 2024-05-31 Strip description for the invitro quantitative determination of glucose in human plasma from whole blood samples
• 00015482771027 - SPOTCHEM™ II Uric Acid: 2024-05-31 Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples
• 00015482771034 - SPOTCHEM™ II Total Cholesterol: 2024-05-31 Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples
• 00015482771041 - SPOTCHEM™ II Triglycerides: 2024-05-31 Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples
• 00015482771058 - SPOTCHEM™ II BUN: 2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
• 00015482771065 - SPOTCHEM™ II Total Bilirubin: 2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s
• 00015482771072 - SPOTCHEM™ II Calcium: 2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples