AccessGUDID - DEVICE: QIAcube Connect MDx (04053228039129)

GUDID

Device Identifier (DI) Information

Brand Name: QIAcube Connect MDx
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9003070
Company Name: QIAGEN GmbH

Primary DI Number: 04053228039129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317103745 *Terms of Use

Device Description: The QIAcube Connect MDx system is a fully automated, sample preparation system, processing up to 12 samples using silica spin columns technology. The QIAcube Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the QIAcube Connect MDx system for the protocols described in the instructions for use of the respective kits. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAcube Connect IVD system.

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?
57871	Specimen processing instrument IVD	An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.	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
Handling Environment Temperature: between 20 and 25 Degrees Celsius
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02fa965e-e5bb-45f7-9bd3-3a3459f4a9eb
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: August 31, 2022