EpochR-SI
Catalogue number EpochR-SI, listed by Agilent Technologies, Inc, United States, under Colorimeter, Photometer, Spectrophotometer For Clinical Use. 13 manufacturers in China are registered for this product code.
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 | Agilent Technologies, Inc, United States |
|---|---|
| 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-01 |
| Record revised | 2022-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EpochR-SI | No Device Sizes | 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-03-12 | Not classified | Software design | Software design allowed false negatives to be read when wells are dark. | 13 | 2015-05-18 |
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.