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Atellica IM Tg

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
Atellica IM Tg FDA UDI
Generic Name
Thyroglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Thyroglobulin (Tg) - Atellica IM - RGT - 500T FDA UDI
Model / Reference
11200534 FDA UDI
Description
Thyroglobulin (Tg) - Atellica IM - RGT - 500T FDA UDI

Identifiers

Catalog Number
11200534 FDA UDI
Primary DI / UDI-DI
00630414238425 FDA UDI
510(k) Number
K242981 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

No

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

Atellica IM Tg by Siemens Healthcare Diagnostics Products Ltd — 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

K242981 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 447c4b25-b2cf-4703-9633-2cb5f462d9b0 37 fields · synced May 30, 2026