HerpeSelect® 1 and 2 Immunoblot IgG

GUDID 20816101021004

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

• Primary Device ID: 20816101021004
• NIH Device Record Key: 7aae30e4-6efe-42f0-95f2-3ca17c7b5285
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HerpeSelect® 1 and 2 Immunoblot IgG
• Version Model Number: IB0900G
• 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: 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: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101021004 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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