Identity
- Trade Name
- E-cadherin FDA UDI
- Generic Name
- Cadherin protein IVD, antibody FDA UDI
- Model / Reference
- NPAI170T40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627039927 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Cadherin 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
Yes
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
Category: Cadherin protein IVD, antibody
E-cadherin by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cadherin protein IVD, antibody.
- Rabbit Monoclonal Anti-Human E-Cadherin (EP6) — EPITOMICS, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Cadherin-17 (SP183) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Ksp-cadherin Antibody, EP296 — EPITOMICS, INC. · Class I
- FLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU (Dako Omnis) — Agilent Technologies Inc. · Class I
- Ksp-cadherin (MRQ-33) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Cadherin-17 (SP183) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · 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
- Biocare Medical, Llc
Sources (1)
- FDA UDI efd34886-3b47-49b4-9965-67a96d430365 33 fields · synced Jun 8, 2026