Home › Device types › MYA
Immunohistochemistry Antibody Assay, Estrogen Receptor
FDA product code MYA · Class 2 · Hematology
50
Registered devices
19
Adverse events
3
Recalls
12
510(k) clearances
Devices with this code
Anti-ER — BIOGENEX LABORATORIESEstrogen Receptor (ER) [1D5] — BIOCARE MEDICAL LLCEstrogen Receptor, Ready to use IHC (UVLP) — RICHARD-ALLAN SCIENTIFIC COMPANYCONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems, Inc.Estrogen Receptor, Culture Supernatant with azide — RICHARD-ALLAN SCIENTIFIC COMPANYEstrogen Receptor (ER) [SP1] — BIOCARE MEDICAL LLCAnti-ER (Insite) — BIOGENEX LABORATORIESEstrogen Receptor (ER) [1D5] — BIOCARE MEDICAL LLCEstrogen Receptor (ER) [1D5] — BIOCARE MEDICAL LLCEstrogen Receptor (ER) [SP1] — BIOCARE MEDICAL LLCEstrogen Receptor (ER) [6F11 + SP1] — BIOCARE MEDICAL LLCCONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems, Inc.Estrogen Receptor, Culture Supernatant with azide — RICHARD-ALLAN SCIENTIFIC COMPANYAnti-ER (Insite) — BIOGENEX LABORATORIESEstrogen Receptor (ER) [SP1] — BIOCARE MEDICAL LLCEstrogen Receptor (ER) [1D5] — BIOCARE MEDICAL LLCEstrogen Receptor, Culture Supernatant with azide — RICHARD-ALLAN SCIENTIFIC COMPANYEstrogen Receptor (ER) [6F11 + SP1] — BIOCARE MEDICAL LLCBOND™ — LEICA BIOSYSTEMS NEWCASTLE LTDANTI-ESTROGEN RECEPTOR-ALPHA — BIOGENEX LABORATORIESAnti-ER (Insite) — BIOGENEX LABORATORIESEstrogen Receptor (ER) [1D5] — BIOCARE MEDICAL LLCEstrogen Receptor (ER) [SP1] — BIOCARE MEDICAL LLCEstrogen Receptor (ER) [6F11] — BIOCARE MEDICAL LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-02 | Ventana Medical Systems Inc | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
| 2011-05-16 | Ventana Medical Systems Inc | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lot |
| 2011-05-16 | Ventana Medical Systems Inc | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lot |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.