AccessGUDID - DEVICE: Accutest (10763924935632)

GUDID

Device Identifier (DI) Information

Brand Name: Accutest
Version or Model: DS93S625
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS93S625
Company Name: JANT PHARMACAL CORPORATION

Primary DI Number: 10763924935632
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 797393659 *Terms of Use

Device Description: Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO and OPI300

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:	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
JXO	Enzyme Immunoassay, Cocaine
LDJ	Enzyme Immunoassay, Cannabinoids
DKZ	Enzyme Immunoassay, Amphetamine
JXM	Enzyme Immunoassay, Benzodiazepine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082898	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: ae23ced2-ef01-4daf-a3ed-c271105e944b
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: March 05, 2019