Dako

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Inc.

Identity

Trade Name: Dako FDA UDI
Generic Name: Wilms tumour protein IVD, antibody FDA UDI
Device Name: Monoclonal Mouse Anti-Human Wilms' Tumor 1 (WT1) Protein Clone 6F-H2 FDA UDI
Model / Reference: M3561 FDA UDI
Description: Monoclonal Mouse Anti-Human Wilms' Tumor 1 (WT1) Protein Clone 6F-H2 FDA UDI

Identifiers

Primary DI / UDI-DI: 05700571102244 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Wilms tumour 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Milliliter FDA UDI

Category: Wilms tumour protein IVD, antibody

Dako by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Rabbit Monoclonal Anti-Human Wilms' Tumor Antibody, EP122 — EPITOMICS, INC. · Class I
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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: Agilent Technologies Inc.

Sources (1)

FDA UDI 7b0f7914-6eb4-42fb-b275-54a2fcb46b98 36 fields · synced Jun 8, 2026