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Dimension Vista® DRUG 4 CAL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® DRUG 4 CAL FDA UDI
Generic Name
Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
Drug 4 Calibrator, 2x5x2.5mL FDA UDI
Model / Reference
10476171 FDA UDI
Description
Drug 4 Calibrator, 2x5x2.5mL FDA UDI

Identifiers

Catalog Number
KC460A FDA UDI
Primary DI / UDI-DI
00842768035319 FDA UDI
510(k) Number
K112142 FDA UDI
FDA Product Code
JIX FDA UDI
GMDN Term
Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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-therapy therapeutic drug monitoring IVD, calibrator

Dimension Vista® DRUG 4 CAL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-therapy therapeutic drug monitoring IVD, calibrator.

Cleared under the same submission

K112142 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 f2fd51f4-f112-4d84-871a-c42bf92bf7a8 37 fields · synced May 30, 2026