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Dimension Vista® Flex® reagent cartridge TU

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge TU FDA UDI
Generic Name
Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA) FDA UDI
Device Name
Thyronine Uptake Flex® reagent cartridge, 160 tests FDA UDI
Model / Reference
10445102 FDA UDI
Description
Thyronine Uptake Flex® reagent cartridge, 160 tests FDA UDI

Identifiers

Catalog Number
K6075 FDA UDI
Primary DI / UDI-DI
00842768015496 FDA UDI
FDA Product Code
KHQ FDA UDI
GMDN Term
Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1715 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge TU by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 8083103d-1bda-4f88-b379-3dd0a7945e1d 36 fields · synced May 30, 2026