Identity
- Trade Name
- Genemed® FDA UDI
- Generic Name
- Melanosome IVD, antibody FDA UDI
- Device Name
- anti-Melanosome Mouse Monoclonal Antibody [HMB45], Ready-To-Use, 7 mL FDA UDI
- Model / Reference
- 60-0042-7 FDA UDI
- Description
- anti-Melanosome Mouse Monoclonal Antibody [HMB45], Ready-To-Use, 7 mL FDA UDI
Identifiers
- Catalog Number
- 60-0042-7 FDA UDI
- Primary DI / UDI-DI
- 00615233006578 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Melanosome 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: Melanosome IVD, antibody
Genemed® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Melanosome IVD, antibody.
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- HMB45 — BIOCARE MEDICAL, LLC · Class I
- HMB45 — BIOCARE MEDICAL, LLC · Class I
- Mono Mo A-Hu Melanosome Cl HMB45 — Agilent Technologies Inc. · Class I
- FLEX Mono Mo A-Hu Melanosome Cl HMB45 RTU (Link) — Agilent Technologies Inc. · Class I
- HMB45 — BIOCARE MEDICAL, LLC · Class I
- HMB45 — BIOCARE MEDICAL, LLC · Class I
- HMB45 — 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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 61ce2865-0afc-4f03-a470-763536f48623 35 fields · synced May 30, 2026