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Reagent

FDA UDI

Class I (US FDA UDI)

by Chromsystems Instruments & Chemicals GmbH

Identity

Trade Name
Reagent FDA UDI
Generic Name
HVA/VMA/5HIAA IVD, reagent FDA UDI
Device Name
Internal Standard, VMA, HVA, 5-HIAA in urine, Preparation with the Gilson® ASPEC FDA UDI
Model / Reference
1044/B/A9 FDA UDI
Description
Internal Standard, VMA, HVA, 5-HIAA in urine, Preparation with the Gilson® ASPEC FDA UDI

Identifiers

Catalog Number
1044/B/A9 FDA UDI
Primary DI / UDI-DI
04250317500533 FDA UDI
FDA Product Code
CDF FDA UDI
GMDN Term
HVA/VMA/5HIAA IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1795 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: HVA/VMA/5HIAA IVD, reagent

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

Similar devices

Also classified as HVA/VMA/5HIAA IVD, reagent.

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 60388468-9e57-4cc6-b0ae-74cad560230f 37 fields · synced Jun 1, 2026