Excyte®

GUDID 03661540700118

ELITechGroup B.V.

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: 03661540700118
• NIH Device Record Key: b5530fe2-9a91-4d53-80bc-07e9b79d9fcb
• Commercial Distribution Discontinuation: 2019-01-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Excyte®
• Version Model Number: 20
• Company DUNS: 415733737
• Company Name: ELITechGroup B.V.
• 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	03661540700118 [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: 5
• Public Version Date: 2022-09-16
• Device Publish Date: 2016-11-21

On-Brand Devices [Excyte® ]

• 03661540700675: Plastic ESR Vacuum Tube High Altitude
• 03661540700668: Plastic ESR Vacuum Tube
• 03661540700613: ESR Non-Vacuum Tube
• 03661540700606: ESR Vacuum Tube
• 03661540700446: DUO-MIX
• 03661540700125: 20
• 03661540700118: 20
• 03661540700071: Mini
• 03661540700064: Mini