CUBE 30 touch 10395

GUDID 08033891322069

DIESSE DIAGNOSTICA SENESE SPA

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: 08033891322069
• NIH Device Record Key: a1b3fd8f-8792-4ee6-bb0a-359fb3523818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUBE 30 touch
• Version Model Number: 10395
• Catalog Number: 10395
• Company DUNS: 435036669
• Company Name: DIESSE DIAGNOSTICA SENESE SPA
• 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: true
• 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	08033891322069 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-05
• Device Publish Date: 2022-11-25

Devices Manufactured by DIESSE DIAGNOSTICA SENESE SPA

• 08033891320010 - CHORUS ECHINOCOCCUS IgG: 2024-01-30
• 08033891320522 - VACU-TEC: 2024-01-30
• 08033891320645 - VACU-TEC CUVETTE-L: 2024-01-30
• 08033891320690 - VES-TEC CUVETTE-L: 2024-01-30
• 08033891321086 - VACU-TEC S.C.: 2024-01-30
• 08033891321093 - VACU-TEC S.C. STERILE: 2024-01-30
• 08033891322083 - CHORUS Q FEVER PHASE II IgG: 2024-01-30
• 08033891322434 - CHORUS MEASLES IgG: 2024-01-30