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Immunohistochemistry Assay, Antibody, Progesterone Receptor

FDA product code MXZ · Class 2 · Hematology

33
Registered devices
9
Adverse events
3
Recalls
13
510(k) clearances

Devices with this code

Anti-PR — BIOGENEX LABORATORIESBOND™ — LEICA BIOSYSTEMS NEWCASTLE LTDFLEX Mono Mo A-Hu Progesterone Receptor Cl PgR 1294 RTU (Dako Omnis) — AGILENT TECHNOLOGIES, INC.Progesterone Receptor (PR) [PgR636] — BIOCARE MEDICAL LLCProgesterone Receptor (PR) [PgR636] — BIOCARE MEDICAL LLCMono Mo A-Hu Progesterone Receptor, Cl PgR 636 — AGILENT TECHNOLOGIES, INC.CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems, Inc.Dako ER/PR pharmDx Kit For the Dako Autostainer — AGILENT TECHNOLOGIES, INC.ANTI-HUMAN PROGESTERONE RECEPTOR — BIOGENEX LABORATORIESCONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems, Inc.BOND™ — LEICA BIOSYSTEMS NEWCASTLE LTDProgesterone Receptor Ready to use IHC (Quanto) — RICHARD-ALLAN SCIENTIFIC COMPANYMono Mo A-Hu Progesterone Receptor, Cl PgR 636 — AGILENT TECHNOLOGIES, INC.Anti-PR (Insite) — BIOGENEX LABORATORIESProgesterone Receptor Culture Supernatant with azide — RICHARD-ALLAN SCIENTIFIC COMPANYProgesterone Receptor Ready to use IHC (UVLP) — RICHARD-ALLAN SCIENTIFIC COMPANYProgesterone Receptor (PR) [16] — BIOCARE MEDICAL LLCProgesterone Receptor Culture Supernatant with azide — RICHARD-ALLAN SCIENTIFIC COMPANYFLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link) — AGILENT TECHNOLOGIES, INC.Progesterone Receptor [PgR636] — BIOCARE MEDICAL LLCAnti-PR (Insite) — BIOGENEX LABORATORIESAnti-PR (Insite) — BIOGENEX LABORATORIESNovocastra™ — LEICA BIOSYSTEMS NEWCASTLE LTDAnti-PR (Insite) — BIOGENEX LABORATORIES

Recent recalls

DateFirmReason
2018-08-02Ventana Medical Systems IncLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
2004-04-06Zymed Laboratories Inc.Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
2004-04-06Zymed Laboratories Inc.Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.