AccessGUDID - DEVICE: Single Drug Urine Test Panel (00817405021093)

GUDID

Device Identifier (DI) Information

Brand Name: Single Drug Urine Test Panel
Version or Model: AWDMO-114
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AWDMO-114
Company Name: Instant Technologies, Inc.

Primary DI Number: 00817405021093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 019410187 *Terms of Use

Device Description: Morphine (MOP) Single Drug Urine Test Panel

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):	Yes
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?
46994	Multiple drugs of abuse 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 of abuse 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
DJG	Enzyme Immunoassay, Opiates

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133968	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 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ccdeba2e-0c54-4e9c-aa1e-432b21e46db9
Public Version Date: October 14, 2024
Public Version Number: 8
DI Record Publish Date: March 10, 2020