Dimension Vista® Flex® reagent cartridge GLU

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension Vista® Flex® reagent cartridge GLU FDA UDI
Generic Name: Glucose IVD, kit, spectrophotometry FDA UDI
Device Name: Glucose Flex® reagent cartridge, 480 tests FDA UDI
Model / Reference: 10445162 FDA UDI
Description: Glucose Flex® reagent cartridge, 480 tests FDA UDI

Identifiers

Catalog Number: K1039 FDA UDI
Primary DI / UDI-DI: 00842768015663 FDA UDI
510(k) Number: K061655 FDA UDI
FDA Product Code: CFR FDA UDI
GMDN Term: Glucose IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 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: Glucose IVD, kit, spectrophotometry

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

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Also classified as Glucose IVD, kit, spectrophotometry.

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Glucose HK — Roche Diagnostics Corp. · Class II
ARCHITECT — Abbott Laboratories, Inc. · Class II
ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc. · Class II
ACCU-CHEK GUIDE LINK — Roche Diagnostics Operations, Inc. · Class III
Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · 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

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 048a75e6-308c-4316-a314-189d5d7717d1 37 fields · synced May 31, 2026