HBsAg Confirmatory Test

GUDID E125N014308

DIASORIN SPA

Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: E125N014308
• NIH Device Record Key: f556a2a7-79de-4500-a33e-ab69001b5939
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HBsAg Confirmatory Test
• Version Model Number: N0143
• Company DUNS: 630822989
• Company Name: DIASORIN SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 651-439-9710
• Email: info@diasorin.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E125N014308 [Primary]

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: 2018-03-29
• Device Publish Date: 2014-09-25

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