Spartan RX CYP2C19 System
The Spartan RX Sample Transport System is an accessory set for moving the sample and collection materials used in a Spartan RX CYP2C19 workflow. The filed set contains a carrying bag, cold…
The Spartan RX Sample Transport System is an accessory set for moving the sample and collection materials used in a Spartan RX CYP2C19 workflow. The filed set contains a carrying bag, cold block and insulated box, rather than the analyzer or assay itself.
In the documented workflow, a buccal swab is placed in a reagent tube and the sample is transported in the insulated system before analysis. The cold block and insulated container serve the temperature-controlled transport role; the set connects sample collection to the later analyzer workflow.
Listed Item
The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373).
Transport in the Sample Workflow
NICE describes the Spartan RX transport arrangement as an insulated bag, polystyrene box and cold block used to keep collection kits and samples cold before testing. This locates the kit between collection and analysis: it carries materials for the CYP2C19 test workflow but does not perform the molecular analysis.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
| Xiamen Zeesan Biotech Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
| Jiangsu Bioperfectus Technologies Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 3 |
| Shanghai ZJ BIO-Tech Co., Ltd. | Shanghai | Shanghai | Private-label distributor | 3 |
Record
| Listed by | Spartan Bioscience, Inc., United States |
|---|---|
| FDA product code | NSU |
| Device type | Instrumentation For Clinical Multiplex Test Systems |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| 510(k) | K123891 |
| Record published | 2016-09-26 |
| Record revised | 2020-07-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01003374, 01003372, and 01003373 | In distribution | |
| 01003359 | In distribution | |
| 01004777 | In distribution | |
| 01004872-ABC | In distribution | |
| 01003438 | In distribution | |
| 01004985 | In distribution | |
| 01004880-ABC (20) | In distribution | |
| 01003214 | In distribution | |
| 01004880-ABC (10) | In distribution | |
| 01004985 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| Aptima® | Hologic, Inc. | 7 |
| OpsisDx | Entopsis, Inc. | 5 |
| Affymetrix | Affymetrix, Inc. | 4 |
| FilmArray® 2.0 Instrument Ngds Configuration | BioFire Defense, LLC | 3 |
| FilmArray® 2.0 Instrument | BioFire Diagnostics, LLC | 3 |
| Opus | Bio-Rad Laboratories Inc. | 3 |
| FilmArray® Torch System Base | BioFire Diagnostics, LLC | 3 |
| FilmArray® Torch Module | BioFire Diagnostics, LLC | 3 |
| Biofire ® Spotfire ® Module | BioFire Diagnostics, LLC | 2 |
| Biofire ® Spotfire ® Control Station | BioFire Diagnostics, LLC | 2 |
| FilmArray® Instrument | BioFire Diagnostics, LLC | 2 |
Showing 12 of 110. All products under Instrumentation For Clinical Multiplex Test Systems
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.