AccessGUDID - DEVICE: AmediCheck Instant Test Cup (00816565020564)

GUDID

Device Identifier (DI) Information

Brand Name: AmediCheck Instant Test Cup
Version or Model: C-C1016A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-C1016A
Company Name: AMEDITECH INC.

Primary DI Number: 00816565020564
Issuing Agency: GS1
Commercial Distribution End Date: January 29, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 010551716 *Terms of Use

Device Description: THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup

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
LDJ	Enzyme Immunoassay, Cannabinoids
NFW	Test, Cannabinoid, Over The Counter
JXM	Enzyme Immunoassay, Benzodiazepine
DKZ	Enzyme Immunoassay, Amphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJG	Enzyme Immunoassay, Opiates
DJR	Enzyme Immunoassay, Methadone
NFV	Test, Benzodiazepine, Over The Counter
DIS	Enzyme Immunoassay, Barbiturate
DJC	Thin Layer Chromatography, Methamphetamine
NGG	Test, Methamphetamine, Over The Counter
NFT	Test, Amphetamine, Over The Counter
NGL	Test, Opiates, Over The Counter
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063379	000
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 36 and 86 Degrees Fahrenheit
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: c21fba5e-31ec-4c6f-afe2-2c9b3e13c9d0
Public Version Date: November 14, 2023
Public Version Number: 7
DI Record Publish Date: March 31, 2017