IMMULITE®/IMMULITE® 1000 Systems T4 Sample Diluent

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: IMMULITE®/IMMULITE® 1000 Systems T4 Sample Diluent FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: Total T4 Sample Diluent - IMMULITE - CAL - 1x25mL FDA UDI
Model / Reference: 10387587 FDA UDI
Description: Total T4 Sample Diluent - IMMULITE - CAL - 1x25mL FDA UDI

Identifiers

Catalog Number: LT4Z FDA UDI
Primary DI / UDI-DI: 00630414954370 FDA UDI
510(k) Number: K910261 FDA UDI
FDA Product Code: KLI FDA UDI
GMDN Term: Buffered sample diluent IVD 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Buffered sample diluent IVD

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

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Also classified as Buffered sample diluent IVD.

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Lumipulse G Specimen Diluent 2 — FUJIREBIO INC. · Class I
ADVIA Centaur® T4 DIL — Siemens Healthcare Diagnostics · Class II
Dimension® Purified Water Diluent — Siemens Healthcare Diagnostics · Class I
ADVIA Centaur® VitD Diluent Bottle — Siemens Healthcare Diagnostics · Class II
ARCHITECT — Abbott Laboratories, Inc. · Class II

Cleared under the same submission

K910261 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI 3e9b1498-11e1-43e7-afa4-778d6ac86fbf 37 fields · synced Jun 8, 2026