AccessGUDID - DEVICE: DOA (05055273202137)

GUDID

Device Identifier (DI) Information

Brand Name: DOA
Version or Model: EV3500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EV3500
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273202137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

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

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:	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCM	Enzyme Immunoassay, Phencyclidine
DJG	Enzyme Immunoassay, Opiates
LDJ	Enzyme Immunoassay, Cannabinoids
JXM	Enzyme Immunoassay, Benzodiazepine
DIS	Enzyme Immunoassay, Barbiturate
DKZ	Enzyme Immunoassay, Amphetamine
DJR	Enzyme Immunoassay, Methadone
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030360	000
K040350	000
K040570	000
K041142	000
K041143	000
K041144	000
K043071	000
K050179	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ca14a85-7068-45a7-abb5-fc5e4c930bbb
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016