AccessGUDID - DEVICE: EDDP CONTROL 1 (05055273207910)

GUDID

Device Identifier (DI) Information

Brand Name: EDDP CONTROL 1
Version or Model: DA3123
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA3123
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273207910
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 1 contains the specific drug EDDP.

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?
43802	2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIF	Drug Mixture Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092258	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
Special Storage Condition, Specify: The EDDP Quality Control materials are stable for 28 days at +2°C to +8ºC.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a51e54c8-b020-4d74-8a60-57cd6425a465
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016