Dimension Vista® Flex® reagent cartridge ACTM

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension Vista® Flex® reagent cartridge ACTM FDA UDI
Generic Name: Acetaminophen IVD, kit, spectrophotometry FDA UDI
Device Name: Acetaminophen Flex® reagent cartridge, 80 tests FDA UDI
Model / Reference: 10445110 FDA UDI
Description: Acetaminophen Flex® reagent cartridge, 80 tests FDA UDI

Identifiers

Catalog Number: K5088 FDA UDI
Primary DI / UDI-DI: 00842768015014 FDA UDI
510(k) Number: K061655 FDA UDI
FDA Product Code: LDP FDA UDI
GMDN Term: Acetaminophen IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Acetaminophen IVD, kit, spectrophotometry

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

Similar devices

Also classified as Acetaminophen IVD, kit, spectrophotometry.

Alinity c Acetaminophen — Sekisui Diagnostics, LLC · Class II
Acetaminophen Liquicolor® — STANBIO LABORATORY, L.P. · Class II
Acetaminophen — Sekisui Diagnostics, LLC
Acetaminophen L3K Assay — Sekisui Diagnostics, LLC · Class II
ONLINE TDM Acetaminophen Gen2 — Roche Diagnostics Corp. · Class II
ACETAMINOPHEN L3K — Sekisui Diagnostics, LLC · Class II
ONLINE TDM Acetaminophen Gen.2 — Roche Diagnostics Corp. · Class II
Dimension® Flex® reagent cartridge ACTM — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K061655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 8ce85ebb-e25a-4164-909b-97d137baeddf 37 fields · synced May 30, 2026