Rabbit Monoclonal Anti-Human Bcl-6 Antibody, EP278

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human Bcl-6 Antibody, EP278 FDA UDI
Generic Name: Bcl-6 protein IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human Bcl-6 (278), 1 mL concentrated FDA UDI
Model / Reference: AC-0242 FDA UDI
Description: Rabbit Monoclonal Anti-Human Bcl-6 (278), 1 mL concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113066387 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Milliliter FDA UDI

Category: Bcl-6 protein IVD, antibody

Rabbit Monoclonal Anti-Human Bcl-6 Antibody, EP278 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bcl-6 protein IVD, antibody.

BOND™ — Leica Biosystems Newcastle, Limited · Class I
FLEX Mono Mo A-Hu BCL6 Protein Cl PG-B6p RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
ANTI-BCL6 — Biogenex Laboratories, 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
Novocastra — Leica Biosystems Newcastle, Limited · 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: Epitomics, Inc.

Sources (1)

FDA UDI 566e272a-f241-4a5e-b3d7-64e77516bdbd 36 fields · synced May 30, 2026