AccessGUDID - DEVICE: Ariel Fluorescent Immunoassay System (04897078440052)

GUDID

Device Identifier (DI) Information

Brand Name: Ariel Fluorescent Immunoassay System
Version or Model: ARIEL220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10102
Company Name: SANWA BIOTECH LIMITED

Primary DI Number: 04897078440052
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687017935 *Terms of Use

Device Description: Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. This device is a fluorescent immunoassay system intended to be used with Test Kits manufactured by Sanwa BioTech. This device is for professional use in a near-patient setting or laboratory use.

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?
56705	Fluorescent immunoassay analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHO	Fluorometer, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d28df53f-a51c-4083-ae88-fd21aae0d03f
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: January 27, 2021