AccessGUDID - DEVICE: Pointe Hydrocodone 100 Reagent Set (00811727016690)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Hydrocodone 100 Reagent Set
Version or Model: 60-HY0760-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-HY0760-100
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727016690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Hydrocodone 100 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Hydrocodone 100 Reagent Set is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at a cutoff value of 100 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?
55462	Multiple drugs of abuse 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 one or multiple drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJG	Enzyme Immunoassay, Opiates

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141055	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: 2355dd94-3c0a-480d-ac80-a40f63e79e96
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 25, 2020