AccessGUDID - DEVICE: PTS Detect® Cotinine System (00381933061017)

GUDID

Device Identifier (DI) Information

Brand Name: PTS Detect® Cotinine System
Version or Model: 3061
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3061
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381933061017
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2020
Device Count: 20
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: Cotinine, the major metabolite of nicotine, indicates exposure to tobacco and other nicotine-containing products. Cotinine has a longer half-life than nicotine, which allows for a more accurate assessment of smoking or exposure status and better monitoring of progress in smoking cessation programs.1 Because of its longer half-life and relative ease of detection, cotinine is the choice metabolite to assess exposure to nicotine. The amount of cotinine present in the blood is proportional to the amount and recency of nicotine exposure. The PTS Detect cotinine system provides measurement of cotinine in capillary (fingerstick) or venous whole blood.

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?
55579	Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cotinine (nicotine metabolite) in a clinical specimen, using an enzyme immunoassay (EIA) method.	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
Special Storage Condition, Specify: Leave all components in their sealed pouches until use.
Special Storage Condition, Specify: If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, Specify: If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, Specify: Store analyzer in protective pouch when not in use.
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 28 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 64 and 82 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46bf859e-f067-4c4c-9f6d-e5438c4e8d44
Public Version Date: April 13, 2022
Public Version Number: 3
DI Record Publish Date: October 08, 2018