Data / Medical devices / System, Test, Radioallergosorbent (Rast) Immunological
System, Test, Radioallergosorbent (Rast) Immunological (DHB): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make System, Test, Radioallergosorbent (Rast) Immunological (product code DHB, Class 2, 21 CFR 866.5750). 7 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 269 510(k) clearances under this code, the latest on September 4, 2026, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DHB
- Device class
- 2
- Regulation
- 866.5750
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Japan | 3 |
| Sweden | 2 |
| United Kingdom | 1 |
Makers of System, Test, Radioallergosorbent (Rast) Immunological
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 20 | August 3, 2022 | 0 | 2 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Manufacturer | 18 | August 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 15 | May 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| Canon Medical Diagnostics USA, Inc. | Mountain View, CA, United States | Manufacturer, Specification developer | 11 | March 19, 2019 | 0 | 1 | 0 | api.fda.gov |
| Hycor Biomedical | Garden Grove, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 11 | July 24, 2026 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 10 | May 28, 2014 | 0 | 2 | 0 | api.fda.gov |
| Medicatec Inc. | Yashio-shi Saitama, Japan | Contract manufacturer, Manufacturer | 1 | December 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| HITACHI HIGH-TECH CORP., Musashimurayama Center | Musashimurayama Tokyo, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HITACHI HIGH-TECH CORP., Ome Works | Ome-Shi Tokyo, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Planet Innovation Products, Inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.