AccessGUDID - DEVICE: THC CONTROL 2 (05055273207965)

GUDID

Device Identifier (DI) Information

Brand Name: THC CONTROL 2
Version or Model: DA3128
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA3128
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273207965
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Randox Cannabinoid Control - Level 2 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 2 contains the specific drug Cannabinoid.

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?
55552	Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092269	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 Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
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: 4cc49efb-c888-45f3-b7f3-7da1011aa82f
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016