ABX Minocal
Catalogue number 5300100300, listed by Horiba ABX SAS, France, under Calibrator For Red-Cell And White-Cell Counting. 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 Jilin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Horiba ABX SAS, France |
|---|---|
| FDA product code | KSA |
| Device type | Calibrator For Red-Cell And White-Cell Counting |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8185 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-09-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5300100300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cal-Chex A Plus | Streck LLC | 2 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 1 |
| SCS-1000 Calibrator | Sysmex Corporation | 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.