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Plasma Calibration Standard

FDA UDI

Class II (US FDA UDI)

by Chromsystems Instruments & Chemicals GmbH

Identity

Trade Name
Plasma Calibration Standard FDA UDI
Generic Name
Mycophenolate therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
Plasma Calibration Standard Mycophenolic Acid FDA UDI
Model / Reference
46003 FDA UDI
Description
Plasma Calibration Standard Mycophenolic Acid FDA UDI

Identifiers

Catalog Number
46003 FDA UDI
Primary DI / UDI-DI
04250317543714 FDA UDI
FDA Product Code
JIX FDA UDI
GMDN Term
Mycophenolate 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

Yes

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

Plasma Calibration Standard by Chromsystems Instruments & Chemicals GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mycophenolate therapeutic drug monitoring IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chromsystems Instruments & Chemicals GmbH

Sources (1)

  • FDA UDI 1f7dfffa-b694-4127-8f47-c2f16477d8cc 37 fields · synced Jun 8, 2026