Identity
- Trade Name
- Novocastra FDA UDI
- Generic Name
- Bcl-6 protein IVD, antibody FDA UDI
- Device Name
- NCL-L-Bcl-6-564-U is intended for the qualitative identification by light microscopy of human Bcl-6 oncoprotein in parrafin sections. FDA UDI
- Model / Reference
- BCL-6-564-L-U FDA UDI
- Description
- NCL-L-Bcl-6-564-U is intended for the qualitative identification by light microscopy of human Bcl-6 oncoprotein in parrafin sections. FDA UDI
Identifiers
- Catalog Number
- NCL-L-BCL-6-564-U FDA UDI
- Primary DI / UDI-DI
- 05055331333216 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Bcl-6 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
Yes
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
No
FDA UDI
Category: Bcl-6 protein IVD, antibody
Novocastra by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bcl-6 protein IVD, antibody.
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- Rabbit Monoclonal Anti-Human Bcl-6 Antibody, EP278 — EPITOMICS, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- FLEX Mono Mo A-Hu BCL6 Protein Cl PG-B6p RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Bcl-6 [LN22] — BIOCARE MEDICAL, LLC · Class I
- BCL6 (EP278) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Bcl-6 Antibody, EP278 — EPITOMICS, INC. · 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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 9b7235e4-a964-4424-80ab-b56ad1f41cd9 36 fields · synced Jun 1, 2026