AccessGUDID - DEVICE: Pointe Oxycodone Reagent Set (00811727017444)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Oxycodone Reagent Set
Version or Model: 60-OX0480-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-OX0480-100
Company Name: HORIBA INSTRUMENTS INCORPORATED

Primary DI Number: 00811727017444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052845583 *Terms of Use

Device Description: Pointe Oxycodone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Oxycodone Reagent Set is intended for the qualitative and semi-quantitative determination of oxycodone in human urine, at cutoff values of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

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:	No
Prescription Use (Rx):	Yes
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?
62306	Oxycodone 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 oxycodone in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJG	Enzyme Immunoassay, Opiates

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120763	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e50f674-7ed2-45f5-9fc6-ec6e6079ed61
Public Version Date: October 02, 2025
Public Version Number: 2
DI Record Publish Date: September 25, 2020