AccessGUDID - DEVICE: BZG (05055273208047)

GUDID

Device Identifier (DI) Information

Brand Name: BZG
Version or Model: DA4011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA4011
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273208047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) 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?
55570	Cocaine/cocaine metabolite IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113751	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 reagent is stable on board the analyser for 28 days at approximately +10°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: 83ff6c99-b409-427d-8312-fd64b74e86c5
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016