Excyte 20 EX-10318

GUDID 03661540304415

Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

ELITECHGROUP INC.

Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD

• Primary Device ID: 03661540304415
• NIH Device Record Key: 53a5faa4-0f74-4a6d-92a9-22ad2039e52e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excyte 20
• Version Model Number: 20 (8 mm)
• Catalog Number: EX-10318
• 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	03661540304415 [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 20]

• 03661540304422: Automated Erythrocyte Sedimentation Rate (ESR) Analyzer
• 03661540304415: Automated Erythrocyte Sedimentation Rate (ESR) Analyzer