HSV-1 IgG Antigen Wells EL0901

GUDID 10816101022363

DIASORIN MOLECULAR LLC

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

• Primary Device ID: 10816101022363
• NIH Device Record Key: be13eaf3-aee8-407f-83b1-08a6ce3ccb04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HSV-1 IgG Antigen Wells
• Version Model Number: EL0901
• Catalog Number: EL0901
• 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
• 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
• 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	10816101022363 [Primary]

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: 2024-07-08
• Device Publish Date: 2017-07-11

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• 10816101022356 - DxSelect™ - 10X Wash Buffer: 2024-07-08
• 10816101022363 - HSV-1 IgG Antigen Wells: 2024-07-08
• 10816101022363 - HSV-1 IgG Antigen Wells: 2024-07-08
• 10816101022370 - HSV-2 IgG Antigen Wells: 2024-07-08
• 10816101022387 - HerpeSelect ELISA Sample Diluent: 2024-07-08