HSV 1&2 ELITe MGB Assay

GUDID 03661540950025

HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and other materials intended to be used for the qualitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT). This 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.

Elitechgroup Mdx LLC

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

• Primary Device ID: 03661540950025
• NIH Device Record Key: afc733fc-e7ed-4932-8055-3a1968be8645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HSV 1&2 ELITe MGB Assay
• Version Model Number: 1
• Company DUNS: 117458512
• Company Name: Elitechgroup Mdx 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540950025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180559

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-15
• Device Publish Date: 2018-12-14

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