Mutlicode®-RTx HSV 1&2 Kit 3711

GUDID 00840487101032

The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.

LUMINEX CORPORATION

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

• Primary Device ID: 00840487101032
• NIH Device Record Key: ac88ffb3-3cf1-453b-b549-3f3a4eb8fe0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mutlicode®-RTx HSV 1&2 Kit
• Version Model Number: 3711
• Catalog Number: 3711
• Company DUNS: 079686463
• Company Name: LUMINEX CORPORATION
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)327-3290
• Email: support@luminexcorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101032 [Primary]

FDA Product Code

• OQO: Herpes simplex virus nucleic acid amplification assay

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: 2018-03-29
• Device Publish Date: 2016-09-09

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