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Elecsys HE4 Assay

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys HE4 Assay FDA UDI
Generic Name
Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
5950929190 FDA UDI

Identifiers

Catalog Number
5950929190 FDA UDI
Primary DI / UDI-DI
04015630929641 FDA UDI
510(k) Number
K112624 FDA UDI
FDA Product Code
OIU FDA UDI
GMDN Term
Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay

Elecsys HE4 Assay by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K112624 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 5cc44e87-91ce-4703-8e06-74f64be14725 35 fields · synced Jun 8, 2026