QuikRead Go® Instrument
QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits.
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (3), Shanghai (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Guangzhou Konmison Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 10 |
| Genrui Biotech Inc | Shenzhen | Guangdong | Manufacturer | 4 |
| Shanghai Kehua Laboratory System Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Showing 12 of 13. All 13 manufacturers in China registered for Colorimeter, Photometer, Spectrophotometer For Clinical Use
Record
| Listed by | Aidian OY, Finland |
|---|---|
| FDA product code | JJQ |
| Device type | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2300 |
| Establishment | Manufacturer |
| 510(k) | K142993 |
| Record published | 2016-06-01 |
| Record revised | 2022-03-08 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature 15 to 25 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 145218 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 5 |
| StatFax | Awareness Technology, Inc. | 5 |
| eREADER™ | Escreen, Inc. | 4 |
| FastPack® IP System | Qualigen, Inc. | 4 |
| MicroScan | Beckman Coulter, Inc. | 3 |
| Infinite F50 | Tecan Austria Gmbh | 3 |
| Seeker™ | Baebies Inc. | 3 |
| Sunrise-RC/ST Evolyzer | Tecan Austria Gmbh | 2 |
| Sunrise-RC/TW Evolyzer | Tecan Austria Gmbh | 2 |
| DRG:HYBRiD.XL® | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Sunrise | Tecan Austria Gmbh | 2 |
| SUNRISE-RC/6F Evolyzer | Tecan Austria Gmbh | 2 |
Showing 12 of 178. All products under Colorimeter, Photometer, Spectrophotometer For Clinical Use
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.