AccessGUDID - DEVICE: VERDICT®-II (00690286000100)

GUDID

Device Identifier (DI) Information

Brand Name: VERDICT®-II
Version or Model: 601584
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTOX DIAGNOSTICS, INC.

Primary DI Number: 00690286000100
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 137417965 *Terms of Use

Device Description: A qualitative one-step immunochromatographic test for the detection of Cannabinoids (THC) and/or metabolites in human urine.

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:	Yes
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?
30519	Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKE	Reagents, Test, Tetrahydrocannabinol

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003687	000
K982211	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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 009effb3-c50b-410e-a2e0-f04e5a609a64
Public Version Date: November 28, 2022
Public Version Number: 7
DI Record Publish Date: September 16, 2016