MGB Alert HSV-2 Probe Mix ASR, 09N45-002 M800588-am

GUDID 03661540950094

MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.

ELITECH GROUP INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

• Primary Device ID: 03661540950094
• NIH Device Record Key: a9583153-4c60-4696-8d00-b4468adb8bd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGB Alert HSV-2 Probe Mix ASR, 09N45-002
• Version Model Number: M800588-am
• Catalog Number: M800588-am
• Company DUNS: 079696864
• Company Name: ELITECH GROUP INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540950094 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2020-09-22
• Device Publish Date: 2020-09-14

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