CHORUS Q FEVER PHASE II IgG 81171

GUDID 08033891322083

DIESSE DIAGNOSTICA SENESE SPA

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08033891322083
• NIH Device Record Key: 078dc65e-aac7-45e2-a3c8-69133e2f99d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHORUS Q FEVER PHASE II IgG
• Version Model Number: 81171
• Catalog Number: 81171
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033891322083 [Primary]

FDA Product Code

• GPS: Antigen, Cf, Q Fever

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: 2024-01-30
• Device Publish Date: 2024-01-22

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
• 08033891322083 - CHORUS Q FEVER PHASE II IgG: 2024-01-30
• 08033891322434 - CHORUS MEASLES IgG: 2024-01-30