Identity
- Trade Name
- Tissue-Tek Genie® DUO FDA UDI
- Generic Name
- Melan-A/MART-1 peptide IVD, antibody FDA UDI
- Device Name
- anti-Melan A [EP43] / Ki67 [GM010] Antibody Cocktail, 1 RTU cartridge FDA UDI
- Model / Reference
- 8480-M100 FDA UDI
- Description
- anti-Melan A [EP43] / Ki67 [GM010] Antibody Cocktail, 1 RTU cartridge FDA UDI
Identifiers
- Catalog Number
- 8480-M100 FDA UDI
- Primary DI / UDI-DI
- 00615233007971 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Melan-A/MART-1 peptide 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: Ki67 antigen IVD, antibodyMelan-A/MART-1 peptide IVD, antibody
Tissue-Tek Genie® DUO by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Melan-A/MART-1 peptide IVD, antibody.
- MART-1 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Melan A — BIOCARE MEDICAL, LLC · Class I
- MART-1 Cocktail — BIOCARE MEDICAL, LLC · Class I
- ANTI-MELAN-A — Biogenex Laboratories, Inc. · Class I
- Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- MART-1 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- MART-1 Cocktail — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI ffb15302-7c31-4ae4-b6a5-f4124dc0fb5e 35 fields · synced Jun 8, 2026