ALiA FIA Analyser 10101

GUDID 04897078440045

ALiA FIA Analyser (model: DX320) 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. ALiA FIA Analyser is intended to be used alongside with IVD and other test kits developed by Sanwa BioTech. ALiA is to be used for the detection of fluorescent signals in immunoassays for the identification of biomarkers in near-patient testing or for laboratory use.

SANWA BIOTECH LIMITED

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 04897078440045
• NIH Device Record Key: c37756c6-6848-43c9-9397-1d38a784d63a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALiA FIA Analyser
• Version Model Number: DX320
• Catalog Number: 10101
• Company DUNS: 687017935
• Company Name: SANWA BIOTECH LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com
• Phone: +85226986612
• Email: support@sanwabiotech.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897078440045 [Primary]

FDA Product Code

• KHO: Fluorometer, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-04
• Device Publish Date: 2021-01-27

Devices Manufactured by SANWA BIOTECH LIMITED

• 04897078440045 - ALiA FIA Analyser: 2021-02-04ALiA FIA Analyser (model: DX320) 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. ALiA FIA Analyser is intended to be used alongside with IVD and other test kits developed by Sanwa BioTech. ALiA is to be used for the detection of fluorescent signals in immunoassays for the identification of biomarkers in near-patient testing or for laboratory use.
• 04897078440045 - ALiA FIA Analyser: 2021-02-04 ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On
• 04897078440052 - Ariel Fluorescent Immunoassay System: 2021-02-04 Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable rapid diagnostic platform with integrated microfl
• 04897078440106 - Thetis Fluorescent Immunoassay System: 2021-02-04 Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid diagnostic platform with integrated microfluidic