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Elecsys T4 Assay

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys T4 Assay FDA UDI
Generic Name
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
12017709122 FDA UDI

Identifiers

Catalog Number
12017709122 FDA UDI
Primary DI / UDI-DI
04015630912728 FDA UDI
510(k) Number
K961490 FDA UDI
FDA Product Code
CDX FDA UDI
GMDN Term
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1700 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: Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

Elecsys T4 Assay by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K961490 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 3442ccdd-b328-4b35-9f1f-454f7c7d68f3 35 fields · synced May 30, 2026