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Dimension Vista® Flex® reagent cartridge PCHE

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge PCHE FDA UDI
Generic Name
Pseudocholinesterase IVD, kit, spectrophotometry FDA UDI
Device Name
Pseudocholinesterase Flex® reagent cartridge, 160 tests FDA UDI
Model / Reference
10445156 FDA UDI
Description
Pseudocholinesterase Flex® reagent cartridge, 160 tests FDA UDI

Identifiers

Catalog Number
K3051 FDA UDI
Primary DI / UDI-DI
00842768015373 FDA UDI
510(k) Number
K061655 FDA UDI
FDA Product Code
DIH FDA UDI
GMDN Term
Pseudocholinesterase IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3240 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

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: Pseudocholinesterase IVD, kit, spectrophotometry

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

Similar devices

Also classified as Pseudocholinesterase IVD, kit, spectrophotometry.

Cleared under the same submission

K061655 also covers:

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 6bc39632-b857-400c-a1d5-d81abd5ed814 37 fields · synced Jun 1, 2026