AccessGUDID - DEVICE: QuickProfile™ Drugs of Abuse Test Cup (M90174046II0)

GUDID

Device Identifier (DI) Information

Brand Name: QuickProfile™ Drugs of Abuse Test Cup
Version or Model: 74046-II
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 74046-II
Company Name: LUMIQUICK DIAGNOSTICS, INC.

Primary DI Number: M90174046II0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790175165 *Terms of Use

Device Description: Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC

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?
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
DJR	Enzyme Immunoassay, Methadone
JXM	Enzyme Immunoassay, Benzodiazepine
DIS	Enzyme Immunoassay, Barbiturate
DKZ	Enzyme Immunoassay, Amphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJG	Enzyme Immunoassay, Opiates
LDJ	Enzyme Immunoassay, Cannabinoids
LCM	Enzyme Immunoassay, Phencyclidine
DJC	Thin Layer Chromatography, Methamphetamine

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
Handling Environment Temperature: between 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 74 Millimeter

Device Record Status

Public Device Record Key: 577468e7-ec5c-43f7-b121-f4e90feff509
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: November 14, 2019