AccessGUDID - DEVICE: MGB Alert Platinum Master Mix, 09N41-005 (03661540951794)

GUDID

Device Identifier (DI) Information

Brand Name: MGB Alert Platinum Master Mix, 09N41-005
Version or Model: M800599-am
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M800599-am
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540951794
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.

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?
60091	Nucleic acid amplification mastermix kit IVD	A collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] in a clinical specimen, using a nucleic acid amplification technique [e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: f56e6312-c99f-42f2-a343-ac00afbae13f
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: September 15, 2020