CHORUS FECAL ELASTASE 86114

GUDID 08033891322786

DIESSE DIAGNOSTICA SENESE SPA

Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08033891322786
• NIH Device Record Key: 6b2f6142-ac81-4b39-9ccf-bc0b6e90df4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHORUS FECAL ELASTASE
• Version Model Number: 86114
• Catalog Number: 86114
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033891322786 [Primary]

FDA Product Code

• JNN: P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

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: 2025-07-09
• Device Publish Date: 2025-07-01

Devices Manufactured by DIESSE DIAGNOSTICA SENESE SPA

• 08033891322748 - CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH: 2025-08-27
• 08033891322779 - CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS: 2025-08-27
• 08033891322670 - CHORUS EVO: 2025-07-09
• 08033891322786 - CHORUS FECAL ELASTASE: 2025-07-09
• 08033891322786 - CHORUS FECAL ELASTASE: 2025-07-09
• 08033891328474 - CHORUS CLIA FECAL ELASTASE: 2025-07-09
• 08033891328481 - CHORUS ELASTASE COPROCOLLECT: 2025-07-09
• 08033891320010 - CHORUS ECHINOCOCCUS IgG: 2024-01-30
• 08033891320522 - VACU-TEC: 2024-01-30