MGB Alert HSV-2 Primer Mix ASR 09N45-003 M800587-am

GUDID 03661540950087

MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.

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: 03661540950087
• NIH Device Record Key: cd68a596-e20e-41ed-b2f1-89722461f3bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGB Alert HSV-2 Primer Mix ASR 09N45-003
• Version Model Number: M800587-am
• Catalog Number: M800587-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	03661540950087 [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

Devices Manufactured by ELITECH GROUP INC.

• 03661540952371 - MGB Alert IC1 Internal Control Template (35uL volume): 2022-07-13 The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an un-assayed internal extraction and amplificat
• 03661540952173 - MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100: 2022-04-12 MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences
• 03661540952180 - MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100: 2022-04-12 MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designe
• 03661540952197 - MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25: 2022-04-12 MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences f
• 03661540952203 - MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100: 2022-04-12 MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences f
• 03661540952210 - MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25: 2022-04-12 MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed
• 03661540952227 - MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-100: 2022-04-12 MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed
• 03661540952258 - MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25: 2022-04-12 The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an un-assayed internal extraction and amplific