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Dimension® CSA Calibrator

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® CSA Calibrator FDA UDI
Generic Name
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
Cyclosporine Calibrator, 1x5x2mL FDA UDI
Model / Reference
10445001 FDA UDI
Description
Cyclosporine Calibrator, 1x5x2mL FDA UDI

Identifiers

Catalog Number
DC89 FDA UDI
Primary DI / UDI-DI
00842768005213 FDA UDI
510(k) Number
K011112 FDA UDI
FDA Product Code
DLJ FDA UDI
GMDN Term
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3200 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

Yes

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: Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® CSA Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator.

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 6c195d46-996a-42d0-8a29-f16b40405d3b 37 fields · synced Jun 6, 2026