AccessGUDID - DEVICE: Evidence MultiSTAT DOA Urine MultiPlex (05055273216752)

GUDID

Device Identifier (DI) Information

Brand Name: Evidence MultiSTAT DOA Urine MultiPlex
Version or Model: EV4393
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EV4393
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273216752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.

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:	No
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?
58886	Multiple drugs of abuse IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple drugs of abuse in a clinical specimen, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DIS	Enzyme Immunoassay, Barbiturate
DJG	Enzyme Immunoassay, Opiates
LCM	Enzyme Immunoassay, Phencyclidine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221550	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5105e85f-03a5-4989-8483-8dc17df01e9c
Public Version Date: September 24, 2024
Public Version Number: 1
DI Record Publish Date: September 16, 2024