AccessGUDID - DEVICE: Personal Care (00808829121612)

GUDID

Device Identifier (DI) Information

Brand Name: Personal Care
Version or Model: Cassette
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DELTA BRANDS INC.

Primary DI Number: 00808829121612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102672008 *Terms of Use

Device Description: Cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing.This Reagent, the Marijuana(THC) Rapid Test Cassette detects 11-nor-Delta9-THC-9-COOH in urine at concentrations equal to or greater than 50 ng/ml. The Marijuana (THC) Test is a rapid qualitative competitive binding immunoassay for determination of Marijuana in 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):	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?
55553	Cannabinoid/cannabinoid metabolite IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0076ec7-a915-42e5-8e78-d0e1383ae87e
Public Version Date: December 21, 2022
Public Version Number: 1
DI Record Publish Date: December 13, 2022