Identity
- Trade Name
- Rabbit Monoclonal Anti-Human NSE, EP319 FDA UDI
- Generic Name
- Neuron-specific enolase (NSE) IVD, antibody FDA UDI
- Device Name
- Rabbit Monoclonal Anti-Human NSE (319), 0.5 mL concentrated FDA UDI
- Model / Reference
- AC-0350B FDA UDI
- Description
- Rabbit Monoclonal Anti-Human NSE (319), 0.5 mL concentrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113069395 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Neuron-specific enolase (NSE) 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
Dimensions & Sizes
- Size
- Total Volume — 0.5 Milliliter FDA UDI
Category: Neuron-specific enolase (NSE) IVD, antibody
Rabbit Monoclonal Anti-Human NSE, EP319 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neuron-specific enolase (NSE) IVD, antibody.
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- NSE (MRQ-55) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- NSE (MRQ-55) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- FLEX Mono Mo A-Hu Neuron-Specific Enolase Cl BBS/NC/VI-H14 RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 cd48e66a-ffd1-4d44-8ae7-de1c20b8a4df 36 fields · synced Jun 8, 2026