Zika ELITe MGB® - EUA

Basic Information

• Brand Name: Zika ELITe MGB® - EUA
• Primary DI: 03661540950018
• Version / Model: M800552
• Catalog Number: M800552
• Company Name: Elitechgroup Mdx LLC
• Labeler DUNS: 117458512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-08
• Public Version: 2
• Public Version Date: 2020-10-15
• Public Version Status: Update
• Public Device Record Key: a69bb12c-33eb-4c0c-a5b5-df4520ac332c

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
49102	Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Zika virus in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540950018	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]