AccessGUDID - DEVICE: Drugs of Abuse Five (5) Panel Test (00840239037732)

GUDID

Device Identifier (DI) Information

Brand Name: Drugs of Abuse Five (5) Panel Test
Version or Model: RAP-3773
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RAP-3773
Company Name: DRG International Inc

Primary DI Number: 00840239037732
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immunochromatography. It is designed for the qualitative determination of 5 drug substances, specifically Amphetamine, Benzodiazepine, Cocaine, Opiate, and Cannabinoid in human urine specimens.

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?
55457	Multiple drugs of abuse IVD, kit, thin layer chromatography	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 thin layer chromatography method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKZ	Enzyme immunoassay, amphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 0984b4be-6be6-40d1-9e1a-d09e396afc38
Public Version Date: July 26, 2023
Public Version Number: 3
DI Record Publish Date: June 10, 2019