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IMMULITE® 2000 Systems THE Theophylline

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® 2000 Systems THE Theophylline FDA UDI
Generic Name
Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Theophyline - IMMULITE - RGT - 200 Tests FDA UDI
Model / Reference
10381539 FDA UDI
Description
Theophyline - IMMULITE - RGT - 200 Tests FDA UDI

Identifiers

Catalog Number
L2KTN2 FDA UDI
Primary DI / UDI-DI
00630414966311 FDA UDI
510(k) Number
K954569 FDA UDI
FDA Product Code
KLS FDA UDI
GMDN Term
Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3880 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: Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems THE Theophylline by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K954569 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 6efec0fe-7628-42ee-a63b-c66f19c0f1a4 37 fields · synced May 30, 2026