B.r.a.h.m.s Kryptor Compact Solution 1
Catalogue number 89981, listed by B.r.a.h.m.s GmbH, Germany, under Fluorometer. 8 manufacturers in China are registered for this product code.
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 | B.r.a.h.m.s GmbH, Germany |
|---|---|
| FDA product code | JZT |
| Device type | Fluorometer |
| Device class | Class 1 |
| Regulation | 21 CFR 866.4520 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-17 |
| Record revised | 2023-06-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89981 | 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 |
| Exdia TRF Plus | Precision Biosensor Inc. | 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.