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Reagent Kit

FDA UDI

Class I (US FDA UDI)

by Chromsystems Instruments & Chemicals GmbH

Identity

Trade Name
Reagent Kit FDA UDI
Generic Name
Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS) FDA UDI
Device Name
MassChrom® Biogenic Amines/Metabolites in urine, Chromatographic Platform FDA UDI
Model / Reference
80000 FDA UDI
Description
MassChrom® Biogenic Amines/Metabolites in urine, Chromatographic Platform FDA UDI

Identifiers

Catalog Number
80000 FDA UDI
Primary DI / UDI-DI
04250317538123 FDA UDI
FDA Product Code
CHQ FDA UDI
GMDN Term
Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1165 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: Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

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

Similar devices

Also classified as Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS).

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 2d18171c-d813-4516-9cb4-0753377a67aa 35 fields · synced May 31, 2026