AccessGUDID - DEVICE: DRUG CONTROL - LEVEL 2 (TDM CONTROL 2) (05055273203585)

GUDID

Device Identifier (DI) Information

Brand Name: DRUG CONTROL - LEVEL 2 (TDM CONTROL 2)
Version or Model: HD1668
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273203585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision.

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?
30503	Multiple therapeutic drugs/drugs of abuse 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 therapeutic drugs and drugs of abuse 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: d8c76b92-781b-4fa4-b9f0-3c0d0df5dfde
Public Version Date: October 12, 2022
Public Version Number: 1
DI Record Publish Date: October 04, 2022