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Dimension Vista® Flex® reagent cartridge E2

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge E2 FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
LOCI Estradiol Flex® reagent cartridge, 320 Tests FDA UDI
Model / Reference
10489099 FDA UDI
Description
LOCI Estradiol Flex® reagent cartridge, 320 Tests FDA UDI

Identifiers

Catalog Number
K6463 FDA UDI
Primary DI / UDI-DI
00842768026461 FDA UDI
FDA Product Code
NDR FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1260 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: Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge E2 by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay.

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 92729b42-9be7-42ad-8aa3-29540c7a2daf 36 fields · synced Jun 8, 2026