Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- Programmed death-ligand 1 (PD-L1) IVD, antibody FDA UDI
- Device Name
- anti-PD-1 Rabbit Monoclonal Antibody [EP239], 1 RTU cartridge FDA UDI
- Model / Reference
- 8287-M250 FDA UDI
- Description
- anti-PD-1 Rabbit Monoclonal Antibody [EP239], 1 RTU cartridge FDA UDI
Identifiers
- Catalog Number
- 8287-M250 FDA UDI
- Primary DI / UDI-DI
- 00615233008350 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Programmed death-ligand 1 (PD-L1) 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: Programmed death-ligand 1 (PD-L1) IVD, antibody
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Programmed death-ligand 1 (PD-L1) IVD, antibody.
- Anti PD-L1 Antibody — INCELLDX, INC · Class I
- MedSource CCN Cup & Tube Only — MEDSOURCE INTERNATIONAL LLC · Class II
- BOND — Leica Biosystems Newcastle, Limited · Class I
- Rabbit Monoclonal Anti-Human PD-L1 Antibody, 28-8 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human PD-L1 Antibody, 28-8 — EPITOMICS, INC. · Class I
- MedSource Continuous Flow Nebulizer w/Mask — MEDSOURCE INTERNATIONAL LLC · Class II
- ANTI-PDL-1 — Biogenex Laboratories, Inc. · Class I
- MedSource Continous Flow Nebulizer, Handheld — MEDSOURCE INTERNATIONAL LLC · Class II
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 b7f0970d-d326-4899-9122-73b4764f1e37 35 fields · synced May 30, 2026