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FDA PRODUCT CODE · CLASS II

PBC — Manual Blood Grouping And Antibody Test Systems

A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.

DEVICE CLASS
Class II
REGULATION
21 CFR 864.9175
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
HE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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