AccessGUDID - DEVICE: PAXgene® Blood RNA Kit (04053727000149)

GUDID

Device Identifier (DI) Information

Brand Name: PAXgene® Blood RNA Kit
Version or Model: Version 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 762164
Company Name: PreAnalytiX GmbH

Primary DI Number: 04053727000149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480915029 *Terms of Use

Device Description: The PAXgene® Blood RNA Kit isolates and purifies RNA from blood collected in a PAXgene® Blood RNA Tube.

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:	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
NTW	System, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082150	000

Device Exempt from Premarket Submission: No 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 25 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5613af38-5f7b-4250-8732-42d0e77c68a7
Public Version Date: March 06, 2025
Public Version Number: 1
DI Record Publish Date: February 26, 2025