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FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link) FDA UDI
- Generic Name
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a Clone EP1 Ready-to-Use (Link) FDA UDI
- Model / Reference
- IR084 FDA UDI
- Description
- FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a Clone EP1 Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571106907 FDA UDI
- 510(k) Number
- K120663 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Estrogen (oestrogen)/progesterone receptor IVD, antibody
FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link) by Agilent Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID
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
- 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 II | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 447ce70e-fd24-4ca5-8993-f08a7cd7ae8d 37 fields · synced May 30, 2026