Para 12 Plus
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 2 vials each of low, normal and high levels.
1manufacturer
7catalogue numbers in this listing
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 | Streck LLC, United States |
|---|---|
| FDA product code | JCN |
| Device type | Control, Cell Counter, Normal And Abnormal |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K901875 |
| Record published | 2016-09-14 |
| Record revised | 2018-07-06 (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 2 to 10 °C |
| Sizes | Total volume 3 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 218903 | Total Volume 3.0 ml | In distribution |
| 218907 | Total Volume 3.0 ml | In distribution |
| 218934 | Total Volume 3.0 ml | In distribution |
| 218913 | Total Volume 3.0 ml | In distribution |
| 230592 | Total Volume 3.0 ml | In distribution |
| 218924 | Total Volume 3.0 ml | In distribution |
| 218914 | Total Volume 3.0 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| STaK-Chex | Streck LLC | 6 |
| Liquichek | Bio-Rad Laboratories Inc. | 5 |
| Cell-DYN | Abbott Laboratories | 2 |
| Advia® 120/2120/2120i TESTpoint High Control | Siemens Healthcare Diagnostics Inc | 1 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 1 |
| 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.