Thetis Fluorescent Immunoassay System 10103

GUDID 04897078440106

Thetis Fluorescent Immunoassay System (THETIS220) 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.

SANWA BIOTECH LIMITED

Fluorescent immunoassay analyser IVD, laboratory, automated
Primary Device ID04897078440106
NIH Device Record Key0489136e-ac4d-4a27-a7f0-2be55d29a2e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameThetis Fluorescent Immunoassay System
Version Model NumberTHETIS220
Catalog Number10103
Company DUNS687017935
Company NameSANWA BIOTECH LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com
Phone+85226986612
Emailsupport@sanwabiotech.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104897078440106 [Primary]

FDA Product Code

KHOFluorometer, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-04
Device Publish Date2021-01-27

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04897078440052 - Ariel Fluorescent Immunoassay System2021-02-04 Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable rapid diagnostic platform with integrated microfl
04897078440106 - Thetis Fluorescent Immunoassay System2021-02-04Thetis Fluorescent Immunoassay System (THETIS220) 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.
04897078440106 - Thetis Fluorescent Immunoassay System2021-02-04 Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid diagnostic platform with integrated microfluidic

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