CONFIRM anti-Topoisomerase II [JS5B4] Rabbit Monoclonal Primary Antibody

FDA UDI

Class I (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name: CONFIRM anti-Topoisomerase II [JS5B4] Rabbit Monoclonal Primary Antibody FDA UDI
Generic Name: Topoisomerase IIa IVD, antibody FDA UDI
Model / Reference: 05479339001 FDA UDI

Identifiers

Catalog Number: 05479339001 FDA UDI
Primary DI / UDI-DI: 04015630972395 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Topoisomerase IIa 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

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Topoisomerase IIa IVD, antibody

CONFIRM anti-Topoisomerase II [JS5B4] Rabbit Monoclonal Primary Antibody by Ventana Medical Systems — Class I — FDA UDI — listed in FDA GUDID

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Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
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Topoisomerase II alpha — 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

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Manufacturer

Manufacturer: Ventana Medical Systems

Sources (1)

FDA UDI 7bf94e78-fa02-48e5-8a2c-55e3f8b7667a 33 fields · synced Jun 8, 2026