AccessGUDID - DEVICE: MDMA CONTROL 2 (05055273207941)

GUDID

Device Identifier (DI) Information

Brand Name: MDMA CONTROL 2
Version or Model: DA3126
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA3126
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273207941
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Randox Ecstasy Control Level 2 is intended for use in the Quality Control of the Ecstasy assay. The Ecstasy Control Level 2 contains the specific drug MDMA (3,4-methylenedioxymethamphetamine).

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:	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?
55491	Amphetamine/methamphetamine group IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092275	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
Special Storage Condition, Specify: Once opened the Ecstasy Quality Control materials are stable for 28 days at +2 to +8ºC.
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: 9509e2b5-12ca-4edf-a382-b59a8a9aac00
Public Version Date: December 20, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016