Capture-P Control Set
The Capture-P Control set is composed of both negative and weak positive control material to control both the Capture-P and Capture-P Ready-Screen tests.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Lilian Precision Mould Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Goju Identification Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Immucor, Inc., United States |
|---|---|
| FDA product code | KSS |
| Device type | Supplies, Blood-Bank |
| Device class | Class 1 |
| Regulation | 21 CFR 864.9050 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | BK860017 |
| Record published | 2016-04-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 1 to 10 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0066248 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rad-Sure™ | Ashland Specialty Ingredients, G.P. | 20 |
| RadTag | Radtag Technologies, Inc. | 12 |
| Cascade | Musculoskeletal Transplant Foundation | 5 |
| MTS | Micro Typing Systems, Inc. | 5 |
| Capture Liss | Immucor, Inc. | 5 |
| GPS® III Platelet Concentration System | Biomet Biologics, LLC | 4 |
| MacoPress Smarter | Delcon SRL | 4 |
| Marketlab Inc | Marketlab Incorporated | 4 |
| Capture-P | Immucor, Inc. | 3 |
| GPS® III | Biomet Biologics, LLC | 2 |
| Typesafe 2.0 | Typenex Medical, LLC | 2 |
| Capture-P Indicator Red Cells | Immucor, Inc. | 2 |
Showing 12 of 48. All products under Supplies, Blood-Bank
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.