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Dimension® QuikLYTE® Integrated Multisensor Sample Diluent

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® QuikLYTE® Integrated Multisensor Sample Diluent FDA UDI
Generic Name
Multiple electrolyte IVD, reagent FDA UDI
Device Name
Sample Diluent, 6x500mL FDA UDI
Model / Reference
10444874 FDA UDI
Description
Sample Diluent, 6x500mL FDA UDI

Identifiers

Catalog Number
S635 FDA UDI
Primary DI / UDI-DI
00842768014017 FDA UDI
510(k) Number
K970330 FDA UDI
FDA Product Code
JFL FDA UDI
JGS FDA UDI
CGZ FDA UDI
CEM FDA UDI
GMDN Term
Multiple electrolyte IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1160 FDA UDI
862.1665 FDA UDI
862.1170 FDA UDI
862.1600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple electrolyte IVD, reagent

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

Similar devices

Also classified as Multiple electrolyte IVD, reagent.

Cleared under the same submission

K970330 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 0a5c5d3d-9134-45e1-b8e5-ff22824e9872 37 fields · synced Jun 1, 2026