AccessGUDID - DEVICE: QIAstat-Dx® Rise (04053228041849)

GUDID

Device Identifier (DI) Information

Brand Name: QIAstat-Dx® Rise
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9003163
Company Name: QIAGEN GmbH

Primary DI Number: 04053228041849
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317103745 *Terms of Use

Device Description: The QIAstat-Dx Rise system is intended as an in-vitro diagnostic device for use with QIAstat-Dx in-vitro diagnostic assays indicated for use with QIAstat-Dx Rise and provides full automation from sample preparation to real-time PCR detection for molecular applications. The system is designed for professional use only and it is not a device for self-testing or near-patient testing.

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?
48031	Thermal cycler nucleic acid amplification analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	Real Time Nucleic Acid Amplification System

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
Handling Environment Temperature: between 0 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ae972a4-fa3b-4fa3-b4df-1b41d0a665a4
Public Version Date: September 15, 2025
Public Version Number: 1
DI Record Publish Date: September 05, 2025