AccessGUDID - DEVICE: ReliOn Home Drug Test Kit 12 Panel (00895330002394)

GUDID

Device Identifier (DI) Information

Brand Name: ReliOn Home Drug Test Kit 12 Panel
Version or Model: RO-DR0012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CONFIRM BIOSCIENCES, INC.

Primary DI Number: 00895330002394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806524968 *Terms of Use

Device Description: Home Drug Test Kit 12 Panel AMP BAR BZD COC MET MOR MTD OXY PCP TCA THC XTC

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):	Yes
Kit:	Yes
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?
46994	Multiple drugs of abuse 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 multiple drugs of abuse 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
DJG	Enzyme Immunoassay, Opiates
DJR	Enzyme Immunoassay, Methadone
JXM	Enzyme Immunoassay, Benzodiazepine
DIS	Enzyme Immunoassay, Barbiturate
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs
LCM	Enzyme Immunoassay, Phencyclidine
DKZ	Enzyme Immunoassay, Amphetamine
DJC	Thin Layer Chromatography, Methamphetamine
DOE	Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DKE	Reagents, Test, Tetrahydrocannabinol

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 8bd10fdf-195a-48ef-ac21-401078591115
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: August 10, 2016