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Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10 FDA UDI
- Generic Name
- CD117 (c-kit) cell marker IVD, antibody FDA UDI
- Device Name
- Rabbit Monoclonal Anti-Human C-Kit/CD117 (10), concentrated FDA UDI
- Model / Reference
- AC-0029BULK FDA UDI
- Description
- Rabbit Monoclonal Anti-Human C-Kit/CD117 (10), concentrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113060996 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD117 (c-kit) cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Category: CD117 (c-kit) cell marker IVD, antibody
Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10 by Epitomics, Inc. — 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
- CD117/c-kit — BIOCARE MEDICAL, LLC · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · 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
- Epitomics, Inc.
Sources (1)
- FDA UDI 11bc80d6-4da3-4ac4-bbd4-b162b9f305e3 35 fields · synced May 31, 2026