Alethia™ HSV 1&2 480650

GUDID 00840733102219

The Alethia™ HSV 1&2 DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Alethia™ HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from Alethia™ HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.

MERIDIAN BIOSCIENCE, INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00840733102219
• NIH Device Record Key: f0049e4c-9066-49cc-bfac-ec8824adaed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alethia™ HSV 1&2
• Version Model Number: 480650
• Catalog Number: 480650
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, 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: true
• 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: 513-271-3700
• Email: info@meridianbioscience.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733102219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151046

FDA Product Code

• PGI: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-09

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