- Physicians Office Resource

"MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein
MGB Alert® EBV Primer Mix ASR - 48 Reactions - 800414

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Epstein-Barr virus (EBV) in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MVU

Device Name: Reagents, Specific, Analyte

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.4020

Third Party Flag: N

Medical Specialty: PA

Device Identifiers

Device Id: 03661540951480

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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