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Rabbit Monoclonal Anti-Human ER Alpha Antibody, EP1
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Rabbit Monoclonal Anti-Human ER Alpha Antibody, EP1 FDA UDI
- Generic Name
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
- Device Name
- Rabbit Monoclonal Anti-Human ER alpha (1), concentrated FDA UDI
- Model / Reference
- AC-0015DKBULK FDA UDI
- Description
- Rabbit Monoclonal Anti-Human ER alpha (1), concentrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113068930 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Estrogen (oestrogen)/progesterone receptor IVD, antibody
Rabbit Monoclonal Anti-Human ER Alpha Antibody, EP1 by Epitomics, Inc. — Class I — 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
- 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
- Novocastra™ — Leica Biosystems Newcastle, Limited · Class II
- Progesterone Receptor (PR) [16] — BIOCARE MEDICAL, LLC · Class II
- Progesterone Receptor (PR) [PgR636] — BIOCARE MEDICAL, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Epitomics, Inc.
Sources (1)
- FDA UDI 40cb461e-6a0f-4bfe-8b7f-563e31887092 35 fields · synced Jun 8, 2026