Identity
- Trade Name
- BOND™ 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 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human estrogen receptor (ER) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
- Model / Reference
- PA0009-U FDA UDI
- Description
- Estrogen Receptor Clone 6F11 Ready-To-Use Primary Antibody For BOND monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human estrogen receptor (ER) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
Identifiers
- Catalog Number
- PA0009-U FDA UDI
- Primary DI / UDI-DI
- 05055331334107 FDA UDI
- 510(k) Number
- K183100 FDA UDI
- FDA Product Code
- MYA FDA UDI
- GMDN Term
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Estrogen (oestrogen)/progesterone receptor IVD, antibody
Bond™ by Leica Biosystems Newcastle, Limited — Class II — FDA UDI — listed in FDA GUDID — 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
Cleared under the same submission
K183100 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 046aaffa-ee81-4c79-b973-b3fd1fa3453f 37 fields · synced Jun 8, 2026