AccessGUDID - DEVICE: Pointe Ecstasy (MDMA) Reagent Set (00811727018007)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Ecstasy (MDMA) Reagent Set
Version or Model: 60-EC0320-1L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-EC0320-1L
Company Name: HORIBA INSTRUMENTS INCORPORATED

Primary DI Number: 00811727018007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052845583 *Terms of Use

Device Description: Pointe Ecstasy (MDMA) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ecstasy (MDMA) Reagent Set is intended for the qualitative and semi-quantitative determination of MDMA and related compounds in human urine at a cutoff value of 500 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?
55493	Amphetamine-specific 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 a specific amphetamine in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKZ	Enzyme Immunoassay, Amphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033094	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: 42d2654b-e1ec-4086-827c-32c8086beca3
Public Version Date: October 02, 2025
Public Version Number: 2
DI Record Publish Date: September 25, 2020