Identity
- Trade Name
- ANTI-NEUROFILAMENT FDA UDI
- Generic Name
- Neurofilament protein IVD, antibody FDA UDI
- Model / Reference
- AM073-5M FDA UDI
Identifiers
- Catalog Number
- AM073-5M FDA UDI
- Primary DI / UDI-DI
- 00810119672247 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Neurofilament protein 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Neurofilament protein IVD, antibody
Anti-Neurofilament by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurofilament protein IVD, antibody.
- Neurofilament (2F11) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- IHC — Slmp, LLC · Class I
- FLEX Mono Mo A-Hu Neurofilament Protein Cl 2F11 RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Neurofilament — BIOCARE MEDICAL, LLC · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 9c3e5476-7a45-4806-bdcf-2107d13ee218 36 fields · synced Jun 6, 2026