AccessGUDID - DEVICE: MagMAX™ Viral/Pathogen Elution Buffer (10190302015806)

GUDID

Device Identifier (DI) Information

Brand Name: MagMAX™ Viral/Pathogen Elution Buffer
Version or Model: A42364LT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: THERMO FISHER SCIENTIFIC BALTICS UAB

Primary DI Number: 10190302015806
Issuing Agency: GS1
Commercial Distribution End Date: January 27, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 644884074 *Terms of Use

Device Description: No description.

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):	Yes
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?
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFT	Reagents for molecular diagnostic test systems

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: 11d6869d-f55f-4d0f-add5-0cc619dc8958
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: October 26, 2022