Teco Diagnostics Cholinesterase Reagent Set
Teco Diagnostics Cholinesterase Reagent Set is used for in vitro diagnostic use in the quantitative kinetic determination of cholinesterase in human serum, plasma, or whole blood.
1manufacturer
1catalogue number
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 | Teco Diagnostics, United States |
|---|---|
| FDA product code | DIH |
| Device type | Colorimetry, Cholinesterase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K914171 |
| Record published | 2023-07-26 |
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 | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C511-60 | 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
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.