Cholinesterase Liquid
The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase activity in serum and plasma by kinetic colorimetric method. The assay is intended…
The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Hebei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Tuosite Technology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
Record
| Listed by | Sentinel CH. SPA, Italy |
|---|---|
| FDA product code | DLI |
| Device type | Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3240 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K981800 |
| Record published | 2017-01-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store between 2 and 8 degrees Celsius |
| Sizes | Total volume 120 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17019H | Total Volume 120 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dimension® Flex® reagent cartridge Pche | Siemens Healthcare Diagnostics Inc | 1 |
| Architect | Abbott Medical | 1 |
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.