Identity
- Trade Name
- Novocastra FDA UDI
- Generic Name
- Multiple CD cell marker IVD, antibody FDA UDI
- Device Name
- For in vitro diagnostic use. NCL-L-CD146 is intended for the qualitative identification by light microscopy of human CD146 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. NCL-L-CD146 is recommended for the assessment of CD146 (MCAM) protein expression in normal and neoplastic tissues. FDA UDI
- Model / Reference
- CD146-L-U FDA UDI
- Description
- For in vitro diagnostic use. NCL-L-CD146 is intended for the qualitative identification by light microscopy of human CD146 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. NCL-L-CD146 is recommended for the assessment of CD146 (MCAM) protein expression in normal and neoplastic tissues. FDA UDI
Identifiers
- Catalog Number
- NCL-L-CD146 FDA UDI
- Primary DI / UDI-DI
- 05055331324078 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Multiple CD cell marker 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: Multiple CD cell marker IVD, antibody
Novocastra by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple CD cell marker IVD, antibody.
- CyFlow™ CD8 APC — EXBIO Praha, a.s. · Class I
- Rabbit Monoclonal Anti-Human CD21 Antibody, EP64 — EPITOMICS, INC. · Class I
- CyFlow™ CD3 FITC — EXBIO Praha, a.s. · Class I
- CyFlow™ CD79b PE — EXBIO Praha, a.s. · Class I
- CyFlow™ Kappa-LC APC — EXBIO Praha, a.s. · Class I
- CyFlow™ CD25 PE — EXBIO Praha, a.s. · Class I
- COULTER CLONE J5-FITC — Beckman Coulter, Inc. · Class I
- CyFlow™ CD20 PerCP-Cy5.5 — EXBIO Praha, a.s. · 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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 32b75baf-54fb-4d5b-8880-c4ac65f0185e 36 fields · synced May 31, 2026