Cfas HbA1c
Catalogue number 4528417190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator For Hemoglobin And Hematocrit Measurement. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | KRZ |
| Device type | Calibrator For Hemoglobin And Hematocrit Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8165 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K052101 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4528417190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CDS Hematology Calibrator | Clinical Diagnostic Solutions, Inc. | 2 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 2 |
| Cal-Chex | Streck LLC | 2 |
| Boule Cal | Clinical Diagnostic Solutions, Inc. | 1 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 1 |
| Architect | Abbott Laboratories | 1 |
| Advia® 120/2120/2120i SETpoint | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 360/560 Calibrator | Siemens Healthcare Diagnostics Inc | 1 |
| Cell-DYN | Abbott Laboratories | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K052101 | 2005-08-26 |
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.