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Plasma Control

FDA UDI

Class I (US FDA UDI)

by Chromsystems Instruments & Chemicals GmbH

Identity

Trade Name
Plasma Control FDA UDI
Generic Name
Tricyclic antidepressant IVD, control FDA UDI
Device Name
MassCheck® Tricylclic Antidepressants TCA 2, Plasma Control Level I FDA UDI
Model / Reference
0247 FDA UDI
Description
MassCheck® Tricylclic Antidepressants TCA 2, Plasma Control Level I FDA UDI

Identifiers

Catalog Number
0247 FDA UDI
Primary DI / UDI-DI
04250317545329 FDA UDI
FDA Product Code
LAS FDA UDI
GMDN Term
Tricyclic antidepressant IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3280 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: Tricyclic antidepressant IVD, control

Plasma Control by Chromsystems Instruments & Chemicals GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tricyclic antidepressant IVD, control.

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 7ec2f75a-23ca-48c7-a2b8-8b7514174951 37 fields · synced May 30, 2026