AccessGUDID - DEVICE: Alere iCup Dx 14 (00817405020010)

GUDID

Device Identifier (DI) Information

Brand Name: Alere iCup Dx 14
Version or Model: I-DX-1147-022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I-DX-1147-022
Company Name: Instant Technologies, Inc.

Primary DI Number: 00817405020010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 019410187 *Terms of Use

Device Description: Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Morphine, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants, CLIA Waived

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122633	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 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26f79adf-a895-4fd9-a923-af888146d53d
Public Version Date: June 10, 2022
Public Version Number: 8
DI Record Publish Date: September 19, 2016