AccessGUDID - DEVICE: Nano-CheckTM Nicotine 500 (00895160002366)

GUDID

Device Identifier (DI) Information

Brand Name: Nano-CheckTM Nicotine 500
Version or Model: AD6183
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AD6183
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002366
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 126544316 *Terms of Use

Device Description: In Vitro Diagnostic Test kit for the detection of Cotinine in human urine

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?
55582	Cotinine (nicotine metabolite) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cotinine (nicotine metabolite) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 92a5a676-26ea-453b-a6c2-beec248b8b91
Public Version Date: June 29, 2023
Public Version Number: 3
DI Record Publish Date: October 04, 2016