AccessGUDID - DEVICE: MGB Alert® EBV Primer Mix ASR

GUDID

Device Identifier (DI) Information

Brand Name: MGB Alert® EBV Primer Mix ASR - 48 Reactions
Version or Model: 800414
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800414
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540951480
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: "MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
49653	Epstein-Barr virus (EBV) 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 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee354eaa-2e88-47ea-a922-cb3a597acdf4
Public Version Date: October 15, 2020
Public Version Number: 2
DI Record Publish Date: September 08, 2020