Acquity
ACQUITY UPLC Column Mgr - Right. Inlet, IVD
3manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Waters Corporation, United States |
|---|---|
| FDA product code | LDM |
| Device type | Instrumentation, High Pressure Liquid Chromatography |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2260 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-01 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -30 to 60 °C; Handling environment humidity up to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 186015082IVD | In distribution | |
| 186015010IVD | In distribution | |
| 186015043IVD | In distribution | |
| 186015046IVD | In distribution | |
| 186015006IVD | In distribution | |
| 186015087IVD | In distribution | |
| 186015042IVD | In distribution | |
| 725000662IVD | In distribution | |
| 186015007IVD | In distribution | |
| 186015001IVD | In distribution | |
| 186015020IVD | In distribution | |
| 186015014IVD | In distribution | |
| 186015000IVD | In distribution | |
| 186015088IVD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| D-10 | Bio-Rad Laboratories Inc. | 3 |
| Hemoglobin Variants System | Bio-Rad Laboratories Inc. | 2 |
| D-100 | Bio-Rad Laboratories Inc. | 1 |
| Variant II | Bio-Rad Laboratories Inc. | 1 |
| Variant II Turbo | Bio-Rad Laboratories Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961557 | 1996-07-05 |
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.