Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- Bcl-2 oncoprotein IVD, antibody FDA UDI
- Device Name
- anti-BCL2 Rabbit Monoclonal Antibody [EP36], 1 RTU cartridge FDA UDI
- Model / Reference
- 8459-M250 FDA UDI
- Description
- anti-BCL2 Rabbit Monoclonal Antibody [EP36], 1 RTU cartridge FDA UDI
Identifiers
- Catalog Number
- 8459-M250 FDA UDI
- Primary DI / UDI-DI
- 00615233002129 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Bcl-2 oncoprotein 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: Bcl-2 oncoprotein 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 Bcl-2 oncoprotein IVD, antibody.
- BCL2 (124) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- BCL2 (E17) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- BCL2 (SP66) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Human Bcl-2 R-PE Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Confirm anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · Class I
- ANTI-BCL-2 ONCOPROTEIN — Biogenex Laboratories, Inc. · Class I
- Bcl-2 — BIOCARE MEDICAL, LLC · Class I
- BCL2 (124) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 73b85485-331f-4a6c-8ebc-2e840bf31121 35 fields · synced May 29, 2026