Excyte EX-10610

GUDID 03661540304408

Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

ELITECHGROUP INC.

Erthrocyte sedimentation rate (ESR) analyser IVD

• Primary Device ID: 03661540304408
• NIH Device Record Key: 5bf92682-c71e-495e-8202-270a48d68021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excyte
• Version Model Number: Mini (9mm)
• Catalog Number: EX-10610
• Company DUNS: 052423787
• Company Name: ELITECHGROUP 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540304408 [Primary]

FDA Product Code

• GKB: Device, Automated Sedimentation Rate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2018-12-26

On-Brand Devices [Excyte]

• 03661540304439: Multifunctional mixer for biological liquids
• 03661540304446: Automated ESR Analyzer (erythrocyte sedimentation rate)
• 03661540304408: Automated Erythrocyte Sedimentation Rate (ESR) Analyzer