AccessGUDID - DEVICE: MEDTOXScan® QC Test Devices (00690286000070)

GUDID

Device Identifier (DI) Information

Brand Name: MEDTOXScan® QC Test Devices
Version or Model: 833075
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTOX DIAGNOSTICS, INC.

Primary DI Number: 00690286000070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137417965 *Terms of Use

Device Description: QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the need for external controls.

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?
56727	Multiplex analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHQ	Multi-Analyte Controls Unassayed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080635	000
K091454	000
K100023	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: cef05c5b-a459-4cdd-9fac-77109666963c
Public Version Date: September 16, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016