Identity
- Trade Name
- Novocastra FDA UDI
- Generic Name
- CD117 (c-kit) cell marker IVD, antibody FDA UDI
- Device Name
- NCL-L-CD117-032-U is intended for the qualitative identification by light microscopy of human c-kit oncoprotein in parrafin sections. FDA UDI
- Model / Reference
- CD117-032-L-U FDA UDI
- Description
- NCL-L-CD117-032-U is intended for the qualitative identification by light microscopy of human c-kit oncoprotein in parrafin sections. FDA UDI
Identifiers
- Catalog Number
- CD117-032-L-U FDA UDI
- Primary DI / UDI-DI
- 05055331333292 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD117 (c-kit) 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: CD117 (c-kit) 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 CD117 (c-kit) cell marker IVD, antibody.
- PATHWAY Anti-c-KIT (9.7) Primary Antibody — Ventana Medical Systems · Class III
- Human CD117 PE-Cy®5.5 Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- ANTI-CD117/C-KIT/SCF — Biogenex Laboratories, Inc. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Rabbit Monoclonal Anti-Human CD117(MXR037) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10 — EPITOMICS, INC. · Class I
- CD117/c-kit — BIOCARE MEDICAL, LLC · Class I
- CD117/c-kit — BIOCARE MEDICAL, LLC · 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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 244114fa-d0d6-40a4-8ff8-e5ea0d0be220 36 fields · synced Jun 8, 2026