DOA

Basic Information

• Brand Name: DOA
• Primary DI: 05055273202397
• Version / Model: EV3542
• Catalog Number: EV3542
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: b5360c00-28b5-4f5b-8502-ad70cb855f82

Device Description

The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays.

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
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	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
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58886	Multiple drugs of abuse IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen, using a multiplex method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273202397	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030360	000
K040350	000
K040570	000
K041142	000
K041143	000
K041144	000
K043071	000
K050179	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius