AccessGUDID - DEVICE: EXPLORO Highly Sensitive NICOTINE URINE TEST (06974246460994)

GUDID

Device Identifier (DI) Information

Brand Name: EXPLORO Highly Sensitive NICOTINE URINE TEST
Version or Model: 15 tests
Commercial Distribution Status: In Commercial Distribution
Catalog Number: COT200NGML
Company Name: Safecare Biotech (Hangzhou) Co., Ltd.

Primary DI Number: 06974246460994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544349634 *Terms of Use

Device Description: No description.

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:	No
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?
66281	Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of nicotine and/or nicotine metabolites (e.g., cotinine) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the differentiation of smokers and non-smokers, or in the investigation of the link between smoking and associated disorders (e.g., cancer, coronary heart disease, stroke). It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRS	Test System, Nicotine, Cotinine, Metabolites

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 288de577-c8cc-494d-a5bf-2db3c3e10690
Public Version Date: December 11, 2023
Public Version Number: 1
DI Record Publish Date: December 01, 2023