Spotfire Control Station – Itar
BIOFIRE SPOTFIRE Control Station IVD ITAR Configuration
9manufacturers in China registered for this device type
1catalogue number
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 | BioFire Defense, LLC, United States |
|---|---|
| FDA product code | NSU |
| Device type | Instrumentation For Clinical Multiplex Test Systems |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K213954 |
| Record published | 2025-12-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FAST-ASY-0001-A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spartan RX CYP2C19 System | Spartan Bioscience, Inc. | 10 |
| 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 |
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.