LIAISON® Control HSV-1 IgG

GUDID 08056771600248

Diasorin Inc.

Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

• Primary Device ID: 08056771600248
• NIH Device Record Key: 69c02dce-316f-4517-9a74-c5d6b1a6ba8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON® Control HSV-1 IgG
• Version Model Number: 310831
• Company DUNS: 033429783
• Company Name: Diasorin Inc.
• 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
• Phone: 651-439-9710
• Email: info@diasorin.com
• Phone: 651-439-9710
• Email: info@diasorin.com
• Phone: 651-439-9710
• Email: info@diasorin.com
• Phone: 651-439-9710
• Email: info@diasorin.com
• Phone: 651-439-9710
• Email: info@diasorin.com
• Phone: 651-439-9710
• Email: info@diasorin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056771600248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081685

FDA Product Code

• MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2026-01-14
• Device Publish Date: 2016-09-24

Devices Manufactured by Diasorin Inc.

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• 08056771600071 - LIAISON® 25 OH Vitamin D TOTAL Control Set: 2026-01-14
• 08056771600088 - LIAISON® 25 OH Vitamin D TOTAL Assay Specimen Diluent: 2026-01-14
• 08056771600095 - LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers: 2026-01-14
• 08056771600101 - LIAISON® HSV-2 Type Specific IgG: 2026-01-14
• 08056771600231 - LIAISON® HSV-1 Type Specific IgG: 2026-01-14
• 08056771600248 - LIAISON® Control HSV-1 IgG: 2026-01-14
• 08056771600248 - LIAISON® Control HSV-1 IgG: 2026-01-14
• 08056771602945 - LIAISON QUANTIferon TB Gold Plus: 2023-09-18 USA manufactured kit