Alere iCup Dx 14

Basic Information

• Brand Name: Alere iCup Dx 14
• Primary DI: 00817405020027
• Version / Model: I-DXA-2147-011
• Catalog Number: I-DXA-2147-011
• Company Name: Instant Technologies, Inc.
• Labeler DUNS: 019410187
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 8
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: dbfd9986-27d9-431f-a1e1-b79c12781e4f

Device Description

Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants with adulteration tests, Bleach, Creatinine, Nitrite, pH and Specific Gravity, CLIA Waived

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
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	862.3700	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	00817405020027	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122633	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit