Identity
- Trade Name
- Genemed® FDA UDI
- Generic Name
- Wilms tumour protein IVD, antibody FDA UDI
- Device Name
- anti-WT1 Mouse Monoclonal Antibody [6F-H2], Ready-To-Use, 7 mL FDA UDI
- Model / Reference
- 60-0135-7 FDA UDI
- Description
- anti-WT1 Mouse Monoclonal Antibody [6F-H2], Ready-To-Use, 7 mL FDA UDI
Identifiers
- Catalog Number
- 60-0135-7 FDA UDI
- Primary DI / UDI-DI
- 00615233006127 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Wilms tumour 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
Yes
FDA UDI
Category: Wilms tumour protein IVD, antibody
Genemed® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wilms tumour protein IVD, antibody.
- IHC — Slmp, LLC · Class I
- Rabbit Monoclonal Anti-Human Wilms' Tumor Antibody, EP122 — EPITOMICS, INC. · Class I
- FLEX Mono Mo A-Hu Wilms’ Tumor 1 (WT1) Protein Cl 6F-H2 RTU (Link) — Agilent Technologies Inc. · Class I
- Mouse Monoclonal Anti-Human WT1(MX012) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Rabbit Monoclonal Anti-Human Wilms' Tumor Antibody, EP122 — EPITOMICS, INC. · Class I
- WT1 [rWT1/857] — BIOCARE MEDICAL, LLC · Class I
- Rabbit Monoclonal Anti-Human Wilms' Tumor Antibody, EP122 — EPITOMICS, INC. · Class I
- IHC — Slmp, 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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 2b10978a-1aad-4564-9186-bd49165b84ee 35 fields · synced Jun 1, 2026