AccessGUDID - DEVICE: DrugCheck (B298307520)

GUDID

Device Identifier (DI) Information

Brand Name: DrugCheck
Version or Model: 30752
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30752
Company Name: EXPRESS DIAGNOSTICS INT'L, INC.

Primary DI Number: B298307520
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 168560402 *Terms of Use

Device Description: 7 Panel Dip Drug Test, AMP-BUP-BZO-COC-MTD-OPI300-OXY

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

FDA Product Code

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Product Code	Product Code Name
DKZ	Enzyme Immunoassay, Amphetamine
JXM	Enzyme Immunoassay, Benzodiazepine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJR	Enzyme Immunoassay, Methadone
DJG	Enzyme Immunoassay, Opiates
LAF	Gas Chromatography, Methamphetamine

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

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Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 583a9e78-4e9e-418b-ba6e-2301fbfbe18d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 12, 2016