AccessGUDID - DEVICE: Nano-CheckTM Nicotine (00895160002359)

GUDID

Device Identifier (DI) Information

Brand Name: Nano-CheckTM Nicotine
Version or Model: AD6083
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AD6083
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002359
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: 793833f7-b362-4dea-a4bc-bf0ba44eae1d
Public Version Date: June 29, 2023
Public Version Number: 3
DI Record Publish Date: September 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10895160002356 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

Phone: 609-409-3300
Email: info@nanoditech.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES