AccessGUDID - DEVICE: L-Cup (00722066006757)

GUDID

Device Identifier (DI) Information

Brand Name: L-Cup
Version or Model: D12.11.1-1VLA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BTNX Inc

Primary DI Number: 00722066006757
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251005005 *Terms of Use

Device Description: L-Cup Rapid Test w/ Adulteration (Urine). For the rapid detection of the following drugs in human urine: MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi

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?
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
DKZ	Enzyme Immunoassay, Amphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DIS	Enzyme Immunoassay, Barbiturate
DJG	Enzyme Immunoassay, Opiates
DJR	Enzyme Immunoassay, Methadone
JXM	Enzyme Immunoassay, Benzodiazepine
LDJ	Enzyme Immunoassay, Cannabinoids
DJC	Thin Layer Chromatography, Methamphetamine
DNK	Thin Layer Chromatography, Morphine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182738	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: efdd5c08-cc37-48c7-92ca-1ec7e523e2b2
Public Version Date: April 20, 2023
Public Version Number: 2
DI Record Publish Date: April 05, 2023