Immulite® Probe Cleaning Kit
For use in daily maintenance of the IMMULITE Systems
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 | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | JJQ |
| Device type | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2300 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K905215 |
| Record published | 2020-09-24 |
| Record revised | 2025-11-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 28 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10385332 | 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.