BD PhoenixSpec™ Calibrator Kit
Catalogue number 440911, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | JQX |
| Device type | Nephelometer, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2700 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-25 |
| Record revised | 2025-05-15 (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 | Storage environment temperature 20 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 440911 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BD BBL™ CrystalSpec™ Calibration Tubes | Becton, Dickinson AND Company | 1 |
| BD Kiestra™ ID AST Calibrator Kit | Becton, Dickinson AND Company | 1 |
| Immage | Beckman Coulter, Inc. | 1 |
| BD PhoenixSpec™ AP Calibrator Kit | Becton, Dickinson AND Company | 1 |
| BD PhoenixSpec™ Calibrator 0.25 McFarland | Becton, Dickinson AND Company | 1 |
| BD PhoenixSpec™ Calibrator 0.50 McFarland | Becton, Dickinson AND Company | 1 |
| BD PhoenixSpec™ Calibrator 2.0 McFarland | Becton, Dickinson AND Company | 1 |
| BD Phoenix™ AP | Becton, Dickinson AND Company | 1 |
| BD PhoenixSpec™ Nephelometer | Becton, Dickinson AND Company | 1 |
| Sensititre Nephelometer | Trek Diagnostic Systems, Ltd. | 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.