Identity
- Trade Name
- Estrogen Receptor 6F11 30 mL EUDAMEDBOND™ FDA UDI
- Generic Name
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
- Device Name
- Estrogen Receptor Clone 6F11 Ready-To-Use Primary Antibody for BOND EUDAMEDEstrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. FDA UDI
- Model / Reference
- PA0009 EUDAMEDFDA UDI
- Description
- Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. FDA UDI
Identifiers
- Catalog Number
- PA0009 FDA UDI
- Primary DI / UDI-DI
- 05055331320421 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331320421 EUDAMED
- FDA Product Code
- MYA FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Estrogen (oestrogen)/progesterone receptor IVD, antibody
Bond™ by Leica Biosystems Newcastle, Limited — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Estrogen (oestrogen)/progesterone receptor IVD, antibody.
- Rabbit Monoclonal Anti-Human Estrogen Receptor(MXR030) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Progesterone Receptor (PR) [16] — BIOCARE MEDICAL, LLC · Class I
- Rabbit Monoclonal Anti-Human ER Alpha Antibody, EP1 — EPITOMICS, INC. · Class I
- Progesterone Receptor (PR) [16] — BIOCARE MEDICAL, LLC · Class I
- Progesterone Receptor [PgR636] — BIOCARE MEDICAL, LLC · Class I
- Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 — Agilent Technologies Inc. · Class II
- Progesterone Receptor (PR) [16] — BIOCARE MEDICAL, LLC · Class II
- Progesterone Receptor (PR) [PgR636] — BIOCARE MEDICAL, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (2)
- FDA UDI 15d43d99-45b2-41e9-ba83-5caeac106f05 36 fields · synced Jun 19, 2026
- EUDAMED 794a745b-a64b-4ae2-a949-7991268bef0a 61 fields · synced Jun 14, 2026