Identity
- Trade Name
- Progesterone Receptor 16 30 mL EUDAMEDBOND FDA UDI
- Generic Name
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
- Device Name
- BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) EUDAMEDBOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems. FDA UDI
- Model / Reference
- PA0436 EUDAMEDFDA UDI
- Description
- BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems. FDA UDI
Identifiers
- Catalog Number
- PA0436 FDA UDI
- Primary DI / UDI-DI
- 05055331320339 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331320339 EUDAMED
- FDA Product Code
- MXZ 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (2)
- FDA UDI 0d2bab81-57f2-4d9b-8679-93a0f3a48e1c 36 fields · synced Oct 6, 2026
- EUDAMED 675c1895-e65a-4d0d-97ae-3b8a2ccedfa0 61 fields · synced Jul 19, 2026