Identity
- Trade Name
- Rabbit Monoclonal Anti-Human EGFR L858R (EP344) FDA UDI
- Generic Name
- Epidermal growth factor receptor (EGFR) IVD, antibody FDA UDI
- Device Name
- Rabbit Monoclonal Anti-Human EGFR L858R (EP344), 1 mL concentrated FDA UDI
- Model / Reference
- AC-0317 FDA UDI
- Description
- Rabbit Monoclonal Anti-Human EGFR L858R (EP344), 1 mL concentrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810138720271 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Epidermal growth factor receptor (EGFR) IVD, antibody FDA UDI
Classification
- Device Class
- Class I 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
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: Epidermal growth factor receptor (EGFR) IVD, antibody
Rabbit Monoclonal Anti-Human EGFR L858R (EP344) by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Epidermal growth factor receptor (EGFR) IVD, antibody.
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- ANTI-EGFR — Biogenex Laboratories, Inc. · Class I
- Epidermal Growth Factor Receptor (EGFR) — BIOCARE MEDICAL, LLC · Class I
- PHOSPHO-EGFR — BIOCARE MEDICAL, LLC · Class I
- Mono Mo A-Hu Epidermal Growth Factor Receptor Cl E30 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ANTI-EGFR — Biogenex Laboratories, Inc. · 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 8f7003df-7ba4-4b04-85d0-9e33d4209ea6 35 fields · synced May 30, 2026