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Dimension® MPA Calibrator

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® MPA Calibrator FDA UDI
Generic Name
Mycophenolate therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
MPAT Calibrator, 1x5mL / 4x2mL FDA UDI
Model / Reference
10445527 FDA UDI
Description
MPAT Calibrator, 1x5mL / 4x2mL FDA UDI

Identifiers

Catalog Number
DC115 FDA UDI
Primary DI / UDI-DI
00842768004902 FDA UDI
510(k) Number
K102772 FDA UDI
FDA Product Code
DLJ FDA UDI
GMDN Term
Mycophenolate 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

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: Mycophenolate therapeutic drug monitoring IVD, calibrator

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

Similar devices

Also classified as Mycophenolate therapeutic drug monitoring IVD, calibrator.

Cleared under the same submission

K102772 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 ad06f3a9-c325-42ee-a2f2-8ed95640d4ab 37 fields · synced Jun 6, 2026