Dimension® QuikLYTE® Integrated Multisensor Diluent Check

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension® QuikLYTE® Integrated Multisensor Diluent Check FDA UDI
Generic Name: Multiple electrolyte IVD, reagent FDA UDI
Device Name: Quiklyte Diluent Check, 60mL FDA UDI
Model / Reference: 10444872 FDA UDI
Description: Quiklyte Diluent Check, 60mL FDA UDI

Identifiers

Catalog Number: S640 FDA UDI
Primary DI / UDI-DI: 00842768014024 FDA UDI
510(k) Number: K970330 FDA UDI
FDA Product Code: CGZ FDA UDI
JGS FDA UDI
JFL FDA UDI
CEM FDA UDI
GMDN Term: Multiple electrolyte IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1170 FDA UDI
862.1665 FDA UDI
862.1160 FDA UDI
862.1600 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, reagent

Dimension® QuikLYTE® Integrated Multisensor Diluent Check by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple electrolyte IVD, reagent.

Urine Diluent — DIAMOND DIAGNOSTICS Inc
Dimension® QuikLYTE® Multisensor Flush Solution — Siemens Healthcare Diagnostics · Class II
Atellica IMT Dilution Check — Siemens Healthcare Diagnostics · Class I
Dimension Vista® V-LTYE® Dilution Check — Siemens Healthcare Diagnostics · Class II
Dimension® QuikLYTE® Integrated Multisensor Sample Diluent — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K970330 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 163865d4-13e5-4c34-b7a2-573a98506dca 37 fields · synced Jun 6, 2026