PBCClass II

Manual Blood Grouping And Antibody Test Systems

21 CFR 864.9175 / Hematology

PBC is the FDA product code for Manual Blood Grouping And Antibody Test Systems, a class II device type, regulated under 21 CFR 864.9175. FDA's definition for this code reads: "A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PBC
Device name: Manual Blood Grouping And Antibody Test Systems
FDA definition: A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Regulation: 21 CFR 864.9175
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PBC

FDA records hold no clearances under product code PBC.

Recent recalls

Product code PBC

FDA records show no recalls under product code PBC.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)