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Thetis Fluorescent Immunoassay System

FDA UDI

Class I (US FDA UDI)

by Sanwa Biotech Limited

Identity

Trade Name
Thetis Fluorescent Immunoassay System FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Device Name
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. FDA UDI
Model / Reference
THETIS220 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
10103 FDA UDI
Primary DI / UDI-DI
04897078440106 FDA UDI
FDA Product Code
KHO FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Fluorescent immunoassay analyser IVD, laboratory

Thetis Fluorescent Immunoassay System by Sanwa Biotech Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sanwa Biotech Limited

Sources (1)

  • FDA UDI 0489136e-ac4d-4a27-a7f0-2be55d29a2e3 36 fields · synced Jun 1, 2026