Dimension Vista® Flex® reagent cartridge URCA

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension Vista® Flex® reagent cartridge URCA FDA UDI
Generic Name: Uric acid IVD, kit, spectrophotometry FDA UDI
Device Name: Uric Acid Flex® reagent cartridge, 560 tests FDA UDI
Model / Reference: 10445145 FDA UDI
Description: Uric Acid Flex® reagent cartridge, 560 tests FDA UDI

Identifiers

Catalog Number: K1077 FDA UDI
Primary DI / UDI-DI: 00842768015519 FDA UDI
510(k) Number: K061655 FDA UDI
FDA Product Code: KNK FDA UDI
GMDN Term: Uric acid IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1775 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: Uric acid IVD, kit, spectrophotometry

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

Similar devices

Also classified as Uric acid IVD, kit, spectrophotometry.

Uric Acid ver.2 — Roche Diagnostics Corp. · Class I
CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT DT212 — Carolina Liquid Chemistries Corp. · Class I
URIC ACID MONO SL — VITALSCIENTIFIC
Alinity — ABBOTT IRELAND · Class I
Alinity — ABBOTT IRELAND · Class I
Uric Acid LiquiColor® — STANBIO LABORATORY, L.P. · Class I
ARCHITECT — ABBOTT IRELAND · Class I
ARCHITECT — Abbott · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 632dcb67-7f96-4261-87fd-02b232043c21 37 fields · synced May 30, 2026