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Whole Blood Calibrator Set

FDA UDI

Class II (US FDA UDI)

by Chromsystems Instruments & Chemicals GmbH

Identity

Trade Name
Whole Blood Calibrator Set FDA UDI
Generic Name
Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants FDA UDI
Model / Reference
28039 FDA UDI
Description
6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants FDA UDI

Identifiers

Catalog Number
28039 FDA UDI
Primary DI / UDI-DI
04250317505125 FDA UDI
FDA Product Code
JIX FDA UDI
GMDN Term
Multiple immunosuppressant 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

Dimensions & Sizes

Size
Total Volume — 2 Milliliter FDA UDI

Category: Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

Whole Blood Calibrator Set by Chromsystems Instruments & Chemicals GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple immunosuppressant 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 6e8da4b8-cb9c-4ba2-9fb7-4685547f6812 37 fields · synced Jun 1, 2026