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Immulite® 2000 Tsi Cvm

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® 2000 TSI CVM FDA UDI
Generic Name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, control FDA UDI
Device Name
IMMULITE(R) 2000 TSI CVM FDA UDI
Model / Reference
10715502 FDA UDI
Description
IMMULITE(R) 2000 TSI CVM FDA UDI

Identifiers

Catalog Number
L2SICVM FDA UDI
Primary DI / UDI-DI
00630414006680 FDA UDI
510(k) Number
K152061 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Thyroid stimulating hormone receptor (TSHR) antibody IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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, control

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

Similar devices

Also classified as Thyroid stimulating hormone receptor (TSHR) antibody IVD, control.

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 123a99b7-dfa0-462a-89f2-19a963a63f08 37 fields · synced Jun 7, 2026