Helmed® Automated IFA Processor
2 catalogue numbers from REF.HEL-1000.US, listed by Aesku.diagnostics GmbH&Co.KG, Germany, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Zhejiang Biorear Biotechnology Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Aesku.diagnostics GmbH&Co.KG, Germany |
|---|---|
| FDA product code | JQW |
| Device type | Station, Pipetting And Diluting, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2750 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-03 |
| Record revised | 2025-01-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REF.HEL-1000.US | In distribution | |
| REF.HEL-1000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Caplugs/Evergreen | Caplugs, Inc. | 37 |
| Janus G3 | Caliper Life Sciences, Inc. | 31 |
| Alinity mp | Abbott Molecular, Inc. | 10 |
| Fontus | Caliper Life Sciences, Inc. | 8 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| Quaero | Zhejiang Biorear Biotechnology Co., Ltd. | 5 |
| Freedom EVO® | Tecan Schweiz AG | 5 |
| Q-Prep | Beckman Coulter, Inc. | 4 |
| Janus G3 Blood iQ | Caliper Life Sciences, Inc. | 4 |
| Globe Scientific | Globe Scientific, LLC | 4 |
| Janus G3 Automated Workstation | Caliper Life Sciences, Inc. | 3 |
| PhD lx | Bio-Rad Laboratories Inc. | 3 |
Showing 12 of 150. All products under Station, Pipetting And Diluting, 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.