QuickProfile™ Drugs of Abuse Test Cup

Basic Information

• Brand Name: QuickProfile™ Drugs of Abuse Test Cup
• Primary DI: M90107RD7205010
• Version / Model: 07RD7205-01
• Catalog Number: 07RD7205-01
• Company Name: LUMIQUICK DIAGNOSTICS, INC.
• Labeler DUNS: 790175165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-27
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 301470ea-239d-4dec-83a7-5c825c9a392c

Device Description

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI / THC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M90107RD7205010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	74	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius