All human products should be treated as potentially infectious. Source material from which this product was derived was found negative when tested in accordance with current FDA required tests. No known test methods can offer assurance that products derived from human blood will not transmit…

The product is tested for purity at a minimum of 20 mg/mL using immunoelectrophoresis. The product is human IgM; no trace of IgG, IgA or non-immunoglobulin serum proteins is detected. The total protein is determined using the Biuret procedure, with bovine albumin as the standard. Each vial is…