Research and Diagnostic Systems
CBC-PIX: 6 x 3.0 mL (2 each Level: Low, Normal, High)
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Research AND Diagnostic Systems, Inc. |
|---|---|
| FDA product code | JCN |
| Device type | Control, Cell Counter, Normal And Abnormal |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Premarket notification | Exempt |
| Record published | 2025-12-01 |
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 | Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIX002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Para 12 Plus | Streck LLC | 7 |
| STaK-Chex | Streck LLC | 6 |
| Liquichek | Bio-Rad Laboratories Inc. | 5 |
| Cell-DYN | Abbott Laboratories | 2 |
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| Advia® 120/2120/2120i TESTpoint Low Control | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 120/2120/2120i 3-in-1 TESTpoint High Control | Siemens Healthcare Diagnostics Inc | 1 |
| OLO Control Kit | S.D. Sight Diagnostics, Ltd. | 1 |
| Advia® 120/2120/2120i TESTpoint Normal Control | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 120/2120/2120i 3-in-1 TESTpoint Normal Control | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 120/2120/2120i 3-in-1 TESTpoint Low Control | Siemens Healthcare Diagnostics Inc | 1 |
| R & D Systems, Inc. CBC-PIX Hematology Control | Research AND Diagnostic Systems, Inc. | 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.