ClearLLab
ClearLLab B1 is a reagent panel used in flow-cytometric immunophenotyping of white blood cells. It supplies antibodies that bind selected cell-surface markers so a flow cytometer can…
Flow Cytometric Test System for Hematopoietic Neoplasms
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
What Is This Device?
Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin’s lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN)
What Is FDA Product Code PWD?
Flow Cytometric Test System For Hematopoietic Neoplasms is FDA product code PWD, Class 2, 21 CFR 864.7010.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.