Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 - 125233, 125242)
The FDA confirmed approval information for several Seraclone blood grouping reagents and anti-human globulin reagents under multiple STN numbers. These products are indicated for the determination of red blood cell antigens and the detection of in vivo or in vitro coating of red blood cells using tube test methodology.
Manufacturers of blood grouping reagents, clinical laboratory personnel performing manual blood typing, and regulatory professionals managing STN-regulated biologics.
The specific designation of these reagents for 'tube test' methodology suggests that their approved use is limited to manual or semi-automated tube techniques. Deviations from this specified testing method could constitute off-label use. This update serves as a baseline for compliance with the approved indications for use for several related products under the cited STN references.
Ensure that laboratory Standard Operating Procedures (SOPs) for blood grouping and anti-human globulin testing align with the specific approved tube test methodology. Regulatory teams should verify that current inventory labels match the specified STN numbers and intended use statements.
Product approval information is indicated for the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test.
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