Data / Medical devices / Lectins And Protectins
Lectins And Protectins (KSI): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Lectins And Protectins (product code KSI, Class 2, 21 CFR 864.9550). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on April 14, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSI
- Device class
- 2
- Regulation
- 864.9550
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 1 |
Makers of Lectins And Protectins
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 |
|---|---|---|---|---|---|---|---|---|
| Alba Bioscience Limited | PENICUIK Midlothian, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hemo Bioscience | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immucor, Inc. | Norcross, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Raritan, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 14, 1982. 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.