Exdia TRF Plus
A reader for the Exdia cartridges (immunofluorescence assay).
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Careomedic Tech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Genrui Biotech Inc | Shenzhen | Guangdong | Manufacturer | 4 |
| Jiangsu Konsung Medical Technology Co., Ltd. | Danyang | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Precision Biosensor Inc. |
|---|---|
| FDA product code | JZT |
| Device type | Fluorometer |
| Device class | Class 1 |
| Regulation | 21 CFR 866.4520 |
| Premarket notification | Exempt |
| Record published | 2022-11-16 |
| Record revised | 2023-07-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PD-FC20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| B.r.a.h.m.s Kryptor compact Solution 2 | B.r.a.h.m.s GmbH | 1 |
| B.r.a.h.m.s Kryptor compact Plus | B.r.a.h.m.s GmbH | 1 |
| B.r.a.h.m.s Kryptor compact Solution 1 | B.r.a.h.m.s GmbH | 1 |
| B.r.a.h.m.s Kryptor compact Solution 3 | B.r.a.h.m.s GmbH | 1 |
| B.r.a.h.m.s Kryptor compact Dilcup | B.r.a.h.m.s GmbH | 1 |
| B.r.a.h.m.s Kryptor compact Solution 4 | B.r.a.h.m.s GmbH | 1 |
| B.r.a.h.m.s Kryptor Buffer | B.r.a.h.m.s GmbH | 1 |
| B.r.a.h.m.s Kryptor compact React | B.r.a.h.m.s GmbH | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.