Ipeak® Reader 4,3″ Lateral Flow Reader
The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.x) is an instrument specifically to be used to provide quantitative, semi-quantitative, and/or qualitative in-vitro determination of…
The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.x) is an instrument specifically to be used to provide quantitative, semi-quantitative, and/or qualitative in-vitro determination of photometric immunochromatographic test defined and marketed by IUL’ partners. The iPeak® reader 4,3” is intended to be used only in combination with lateral flow (LF) tests indicated for use with the iPeak® reader 4,3”, and only for applications that are described in the respective handbooks of our reader associates.
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 | IUL SA, Spain |
|---|---|
| FDA product code | JJQ |
| Device type | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2300 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-14 |
| Record revised | 2023-08-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Handling environment humidity 0 to 75 % RH; Storage environment temperature 5 to 40 °C; Storage environment humidity 0 to 75 % RH |
| Sizes | Width 126.5 mm; length 145 mm; height 140 mm; weight 0.6 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100033000US1 | Width 126.5 mm | 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.