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Elecsys Tg II

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys Tg II FDA UDI
Generic Name
Thyroglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
08906556160 FDA UDI

Identifiers

Catalog Number
08906556160 FDA UDI
Primary DI / UDI-DI
07613336203569 FDA UDI
510(k) Number
K221890 FDA UDI
FDA Product Code
MSW FDA UDI
GMDN Term
Thyroglobulin 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

No

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: Thyroglobulin IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Thyroglobulin IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K221890 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 5fd6bdb3-b6cf-4c95-ad64-1d0209c83aa6 34 fields · synced May 30, 2026