AccessGUDID - DEVICE: MGB Alert® HHV6 2.0 Primer Mix ASR

GUDID

Device Identifier (DI) Information

Brand Name: MGB Alert® HHV6 2.0 Primer Mix ASR - 48 Reactions
Version or Model: 800499
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800499
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540951978
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: "MGB Alert® HHV-6 2.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of a total of 2.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a region of the U67 gene."

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?
49743	Human herpesvirus 6 (HHV6) 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 Human herpesvirus 6 (HHV6) in a clinical specimen, using a nucleic acid technique (NAT).	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: 8496407c-d9bf-46a4-ac85-a279d2cd5292
Public Version Date: October 15, 2020
Public Version Number: 2
DI Record Publish Date: September 08, 2020