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Atellica IM T4

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM T4 FDA UDI
Generic Name
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Total T4 (T4) Atellica IM - RGT 150T FDA UDI
Model / Reference
10995684 FDA UDI
Description
Total T4 (T4) Atellica IM - RGT 150T FDA UDI

Identifiers

Catalog Number
10995684 FDA UDI
Primary DI / UDI-DI
00630414599977 FDA UDI
FDA Product Code
CEC FDA UDI
GMDN Term
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1695 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: Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

Atellica IM T4 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 7dc50922-91c5-46fa-9516-f2c6a3fdc684 36 fields · synced May 30, 2026