Data / Medical devices / Products, Red-Cell Lysing Products / United States
FDA-registered makers of Products, Red-Cell Lysing Products in the United States: 19 establishments
19 establishments in the United States are registered with the FDA to make Products, Red-Cell Lysing Products (product code GGK). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Products, Red-Cell Lysing Products
- Product code
- GGK
- Country
- United States
Makers of Products, Red-Cell Lysing Products in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Antibodies Incorporated | Davis, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc. | Carpinteria, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Chaska, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hialeah, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hebron, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson and Company, BD Biosciences | Milpitas, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Diagnostic Solutions, Inc. | Plantation, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incell Corporation, LLC | San Antonio, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JAS Diagnostics/Drew Scientific | Plantation, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Reagents America, Inc. | Mundelein, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Bioscience, Inc. | Grove City, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.