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IMMULITE®/IMMULITE® 1000 Systems T4 Total T4

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE®/IMMULITE® 1000 Systems T4 Total T4 FDA UDI
Generic Name
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
T4 Total - IMMULITE - RGT - 100 Tests FDA UDI
Model / Reference
10381633 FDA UDI
Description
T4 Total - IMMULITE - RGT - 100 Tests FDA UDI

Identifiers

Catalog Number
LKT41 FDA UDI
Primary DI / UDI-DI
00630414966229 FDA UDI
510(k) Number
K910261 FDA UDI
FDA Product Code
KLI 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

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

IMMULITE®/IMMULITE® 1000 Systems T4 Total T4 by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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

Cleared under the same submission

K910261 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 d12954b0-a0c8-410f-a010-43d932986199 37 fields · synced May 30, 2026