HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control IB0913

GUDID 10816101021021

DIASORIN MOLECULAR LLC

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot

• Primary Device ID: 10816101021021
• NIH Device Record Key: a30822bf-7e2e-46ea-b25d-332cf51bc1d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control
• Version Model Number: IB0913
• Catalog Number: IB0913
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816101021021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000238

FDA Product Code

• LGC: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-04
• Device Publish Date: 2016-09-22

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