AccessGUDID - DEVICE: ImmuTest Drugs of Abuse Screen Card (00816565020007)

GUDID

Device Identifier (DI) Information

Brand Name: ImmuTest Drugs of Abuse Screen Card
Version or Model: IMD-AMP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IMD-AMP
Company Name: AMEDITECH INC.

Primary DI Number: 00816565020007
Issuing Agency: GS1
Commercial Distribution End Date: April 27, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 010551716 *Terms of Use

Device Description: Amphetamine single drug dipcard

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?
55489	Amphetamine/methamphetamine group 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 belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKZ	Enzyme Immunoassay, Amphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113046	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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07592462-75f2-429b-b0f6-bc4021e7c45d
Public Version Date: November 14, 2023
Public Version Number: 8
DI Record Publish Date: September 01, 2016