Asserachrom® Washing Solution
Catalogue number 00555, listed by Diagnostica Stago, Inc., United States, under General Purpose Reagent. 30 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Takara Biotechnology (Dalian) Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
Showing 12 of 30. All 30 manufacturers in China registered for General Purpose Reagent
Record
| Listed by | Diagnostica Stago, Inc., United States |
|---|---|
| FDA product code | PPM |
| Device type | General Purpose Reagent |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2021-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00555 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostic BioSystems | Diagnostic Biosystems | 62 |
| Epredia | Richard-Allan Scientific LLC | 59 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 46 |
| Vysis | Abbott Molecular, Inc. | 34 |
| Genemed® | Sakura Finetek U.S.A., Inc. | 33 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 25 |
| Immunalysis | Immunalysis Corporation | 22 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 22 |
| Bond | Leica Biosystems Newcastle Ltd | 16 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 16 |
| Synchron | Beckman Coulter, Inc. | 13 |
| Immy | Immuno-Mycologics, Inc. | 12 |
Showing 12 of 617. All products under General Purpose Reagent
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-05-21 | Class II | Under Investigation by firm | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% | 939 US ( 2,810 total worldwide) |
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.