AU
Cholinesterase
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | DIH |
| Device type | Colorimetry, Cholinesterase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3240 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K030045 |
| Record published | 2016-09-24 |
| Record revised | 2023-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSR6114 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Advia® Chemistry CHE Cholinesterase Reagents | Siemens Healthcare Diagnostics Inc | 2 |
| Cholinesterase Gen.2 | Roche Diagnostics Gmbh | 2 |
| Butyryl Cholinesterase (CHE) | Randox Laboratories Limited | 2 |
| Dimension Vista® Flex® reagent cartridge Pche | Siemens Healthcare Diagnostics Inc | 1 |
| AChE Assay Kit | EQM Research, Inc. | 1 |
| Arena Star | Arum Dentistry Co., Ltd. | 1 |
| PChE Assay Kit | EQM Research, Inc. | 1 |
| Test-mate ChE Cholinesterase Test System | EQM Research, Inc. | 1 |
| Atellica CH CHE | Siemens Healthcare Diagnostics Inc | 1 |
| Cholinesterase | Roche Diagnostics Gmbh | 1 |
Showing 12 of 14. All products under Colorimetry, Cholinesterase
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103373 | 2011-02-07 |
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.