AccessGUDID - DEVICE: Acuitas (04260364751017)

GUDID

Device Identifier (DI) Information

Brand Name: Acuitas
Version or Model: Curetis Qualified QuantStudio™ 5 Real-Time PCR System
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62006
Company Name: Curetis GmbH

Primary DI Number: 04260364751017
Issuing Agency: GS1
Commercial Distribution End Date: March 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 312621863 *Terms of Use
Previous DI: 20812125010062

Device Description: QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.

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?
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 [?]
K191288	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58ffde7a-143d-44a0-a760-9e5b788178fb
Public Version Date: July 14, 2025
Public Version Number: 4
DI Record Publish Date: April 17, 2023