FDA UDI
In Commercial Distribution
🇺🇸 United States
Thetis Fluorescent Immunoassay System
DI: 04897078440106
·
Model: THETIS220
·
SANWA BIOTECH LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thetis Fluorescent Immunoassay System
- Primary DI
- 04897078440106
- Version / Model
- THETIS220
- Catalog Number
- 10103
- Company Name
- SANWA BIOTECH LIMITED
- Labeler DUNS
- 687017935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-27
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 0489136e-ac4d-4a27-a7f0-2be55d29a2e3
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | Clinical Chemistry | 862.2560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04897078440106 | GS1 |
Customer Contacts
- Phone
- +85226986612
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius