Detector Drug Cup

Basic Information

• Brand Name: Detector Drug Cup
• Primary DI: 10722355002580
• Version / Model: HCDOAV-4125
• Company Name: IMMUNOSTICS COMPANY, INC
• Labeler DUNS: 119214195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2018-05-21
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: ad32c460-96fc-4ad3-83bc-966455f75e47

Device Description

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
LCM	Enzyme immunoassay, phencyclidine	Unknown		U
DIS	Enzyme immunoassay, barbiturate	Clinical Toxicology	862.3150	2
JXM	Enzyme immunoassay, benzodiazepine	Clinical Toxicology	862.3170	2
DJG	Enzyme immunoassay, opiates	Clinical Toxicology	862.3650	2
LDJ	Enzyme immunoassay, cannabinoids	Clinical Toxicology	862.3870	2
LAF	Gas chromatography, methamphetamine	Clinical Toxicology	862.3610	2
DJR	Enzyme immunoassay, methadone	Clinical Toxicology	862.3620	2
DKZ	Enzyme immunoassay, amphetamine	Clinical Toxicology	862.3100	2
DIO	Enzyme immunoassay, cocaine and cocaine metabolites	Clinical Toxicology	862.3250	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
Package	20722355002587	GS1	Case of 4	4	In Commercial Distribution
Primary	10722355002580	GS1
Unit of Use	80722355002589	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep test cup in the package until ready for use. DO NOT FREEZE.