AccessGUDID - DEVICE: ACCUTEST Drug Test Cup 11-Panel CLIA-Waived (10763924811530)

GUDID

Device Identifier (DI) Information

Brand Name: ACCUTEST Drug Test Cup 11-Panel CLIA-Waived
Version or Model: DS811
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JANT PHARMACAL CORPORATION

Primary DI Number: 10763924811530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 797393659 *Terms of Use

Device Description: ACCUTEST Drug Test Cup 11-Panel CLIA-Waived AMP 1000, BAR 300, BZO 300, COC 300, MAD 300, MET 1000, OPI 2000, OXY, PCP 25, TCA 1000 ,THC 50

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
LCM	Enzyme Immunoassay, Phencyclidine
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs
LDJ	Enzyme Immunoassay, Cannabinoids
DJG	Enzyme Immunoassay, Opiates
DJR	Enzyme Immunoassay, Methadone
DJC	Thin Layer Chromatography, Methamphetamine
DKZ	Enzyme Immunoassay, Amphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
JXM	Enzyme Immunoassay, Benzodiazepine
DIS	Enzyme Immunoassay, Barbiturate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071489	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8bbffd3-5f3e-4213-9d1d-a51b6292a041
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2016