Biofire ® Spotfire ® Control Station
Used IVD Instrument (SPOTFIRE® Control Station).
9manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
2recalls on this code
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 Diagnostics, 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K213954 |
| Record published | 2023-04-06 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FAST-ASY-0001-W | In distribution | |
| FAST-ASY-0001 | 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 |
| FilmArray® Instrument | BioFire Diagnostics, LLC | 2 |
Showing 12 of 110. All products under Instrumentation For Clinical Multiplex Test Systems
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143178 | 2015-01-30 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-08-07 | Class II | Under Investigation by firm | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may | 1001 |
| 2023-10-17 | Class II | Device Design | Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power | 5,406 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.