CONFIRM anti-Keratin (34betaE12) Mouse Monoclonal Primary Antibody

FDA UDI

Class I (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name: CONFIRM anti-Keratin (34betaE12) Mouse Monoclonal Primary Antibody FDA UDI
Generic Name: Cytokeratin IVD, antibody FDA UDI
Model / Reference: 05479266001 FDA UDI

Identifiers

Catalog Number: 05479266001 FDA UDI
Primary DI / UDI-DI: 04015630972401 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Cytokeratin 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: Cytokeratin IVD, antibody

CONFIRM anti-Keratin (34betaE12) Mouse Monoclonal Primary Antibody by Ventana Medical Systems — Class I — FDA UDI — listed in FDA GUDID

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Also classified as Cytokeratin IVD, antibody.

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Rabbit Monoclonal Anti-Human Cytokeratin 19 Antibody, EP72 — 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: Ventana Medical Systems

Sources (1)

FDA UDI 97428cb2-c6cb-4133-b905-827368fc81ba 33 fields · synced May 30, 2026