Zika ELITe MGB® - EUA M800552

GUDID 03661540950018

The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitro qualitative detection of Zika virus with specified instruments. This assay tests for Zika virus RNA in human serum and EDTA plasma.

ELITECH GROUP INC.

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• Primary Device ID: 03661540950018
• NIH Device Record Key: a69bb12c-33eb-4c0c-a5b5-df4520ac332c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zika ELITe MGB® - EUA
• Version Model Number: M800552
• Catalog Number: M800552
• Company DUNS: 079696864
• Company Name: ELITECH GROUP 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: 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540950018 [Primary]

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: 2020-09-16
• Device Publish Date: 2020-09-08

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