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Immulite® 2000 Tsi

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® 2000 TSI FDA UDI
Generic Name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
IMMULITE(R) 2000 TSI Assay FDA UDI
Model / Reference
10876421 FDA UDI
Description
IMMULITE(R) 2000 TSI Assay FDA UDI

Identifiers

Catalog Number
L2KSI2(D) FDA UDI
Primary DI / UDI-DI
00630414597188 FDA UDI
510(k) Number
K152061 FDA UDI
FDA Product Code
JZO FDA UDI
GMDN Term
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5870 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: Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

Immulite® 2000 Tsi by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K152061 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 4a91b599-bba0-4d44-aa7f-7b8c9e417330 37 fields · synced Jun 1, 2026