AccessGUDID - DEVICE: Maxwell® CSC Pathogen Total Nucleic Acid Kit (00849811069062)

GUDID

Device Identifier (DI) Information

Brand Name: Maxwell® CSC Pathogen Total Nucleic Acid Kit
Version or Model: AS1860
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS1860
Company Name: PROMEGA CORPORATION

Primary DI Number: 00849811069062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089855696 *Terms of Use

Device Description: The Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of pathogen total nucleic acid from human samples.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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
JJH	Clinical Sample Concentrator

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: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bfdce8ab-9711-4c90-9688-133f8cc53670
Public Version Date: April 16, 2025
Public Version Number: 2
DI Record Publish Date: June 12, 2023