AccessGUDID - DEVICE: MGB Alert MS2 RNA Internal Control in TE-Yeast RNA (03661540951992)

GUDID

Device Identifier (DI) Information

Brand Name: MGB Alert MS2 RNA Internal Control in TE-Yeast RNA
Version or Model: M800698
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M800698
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540951992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: MS2 RNA Internal Control in TE-Yeast RNA

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?
62400	Endogenous DNA/RNA internal control IVD, reagent	A substance or reactant intended to be used as an endogenous component in a molecular assay to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or verify the absence of inhibiting substances, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLD	Internal Polymerase Chain Reaction Control, Not Assay Specific

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
Storage Environment Temperature: less than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c062806d-3530-4476-9e65-cae5592c4495
Public Version Date: March 14, 2023
Public Version Number: 1
DI Record Publish Date: March 06, 2023