AccessGUDID - DEVICE: EtOH (05055273208085)

GUDID

Device Identifier (DI) Information

Brand Name: EtOH
Version or Model: DA4015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA4015
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273208085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The ethanol assay is an in vitro diagnostic test for the quantitative analysis of ethanol in human urine and serum.

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?
55612	Ethanol (ETOH) 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 quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092273	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: Avoid prolonged exposure of the reagent at temperatures higher than +25ºC
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: ad788882-4417-4b18-8d3e-bcc62a35df37
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016