← Back to catalogue

Dimension Vista® DRUG 1 CAL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® DRUG 1 CAL FDA UDI
Generic Name
Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
Drug 1 Calibrator, 3x2x2.5mL FDA UDI
Model / Reference
10445183 FDA UDI
Description
Drug 1 Calibrator, 3x2x2.5mL FDA UDI

Identifiers

Catalog Number
KC410 FDA UDI
Primary DI / UDI-DI
00842768015762 FDA UDI
510(k) Number
K062034 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 1 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 23bf6fc0-e4da-456a-b6d4-dbaf1015bb10 37 fields · synced May 29, 2026