Dimension® QuikLYTE® Integrated Multisensor Standard A

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension® QuikLYTE® Integrated Multisensor Standard A FDA UDI
Generic Name: Multiple electrolyte IVD, calibrator FDA UDI
Device Name: QuikLYTE® Integrated Multisensor Standard A, 3x1 Liter FDA UDI
Model / Reference: 10444878 FDA UDI
Description: QuikLYTE® Integrated Multisensor Standard A, 3x1 Liter FDA UDI

Identifiers

Catalog Number: S620 FDA UDI
Primary DI / UDI-DI: 00842768013997 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Multiple electrolyte IVD, calibrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Multiple electrolyte IVD, calibrator

Dimension® QuikLYTE® Integrated Multisensor Standard A by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID

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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

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI a86d2de4-9392-47e8-9bf6-d7045732786d 36 fields · synced May 30, 2026