SANWA BIOTECH LIMITED

Address:Unit 1-5 & 12, 5/F, Wah Lai Industrial Centre,,Hong Kong,HK

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Fluorometer, For Clinical Use (KHO) (3)

Premarket Exempt

No Yes

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ALiA FIA Analyser - 04897078440045 Catalog Number : 10101

Device Description : ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platfo 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.

Device Class : 1

Duns Number: 687017935

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

Ariel Fluorescent Immunoassay System - 04897078440052 Catalog Number : 10102

Device Description : Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable r 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 Class : 1

Duns Number: 687017935

Premarket Exempt : Yes

Product Code : KHO

Prescription Use : Yes

Device Count : 1

Thetis Fluorescent Immunoassay System - 04897078440106 Catalog Number : 10103

Device Description : Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid 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.

Device Class : 1

Duns Number: 687017935

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

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