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Plasma Control Bi-Level

FDA UDI

Class I (US FDA UDI)

by Chromsystems Instruments & Chemicals GmbH

Identity

Trade Name
Plasma Control Bi-Level FDA UDI
Generic Name
Vitamin B6 complex group IVD, control FDA UDI
Device Name
Plasma Control Bi-Level, Vitamin B6 in plasma/serum FDA UDI
Model / Reference
0031 FDA UDI
Description
Plasma Control Bi-Level, Vitamin B6 in plasma/serum FDA UDI

Identifiers

Catalog Number
0031 FDA UDI
Primary DI / UDI-DI
04250317505439 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Vitamin B6 complex group IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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: Vitamin B6 complex group IVD, control

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

Similar devices

Also classified as Vitamin B6 complex group 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 a2e2fffc-2c56-42be-a067-34285b512b33 37 fields · synced Jun 8, 2026