AccessGUDID - DEVICE: THC (05055273208030)

GUDID

Device Identifier (DI) Information

Brand Name: THC
Version or Model: DA4010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA4010
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273208030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Cannabinoid assay is an in vitro diagnostic reagent for the qualitative and semi-quantitative analysis of Cannabinoids (THC) in human urine.

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?
55553	Cannabinoid/cannabinoid metabolite IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is 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
LDJ	Enzyme Immunoassay, Cannabinoids

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Once opened the reagent is stable on board the analyser for approximately 10°C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b22a14cf-c5dd-4dc6-a0e3-77187c6f6298
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016