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Mdma

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
MDMA FDA UDI
Generic Name
Amphetamine/methamphetamine group IVD, reagent FDA UDI
Device Name
The MDMA assay is an in vitro diagnostic reagent. For the qualitative and semi-quantitative analysis of MDMA in human urine. FDA UDI
Model / Reference
DA4014 FDA UDI
Description
The MDMA assay is an in vitro diagnostic reagent. For the qualitative and semi-quantitative analysis of MDMA in human urine. FDA UDI

Identifiers

Catalog Number
DA4014 FDA UDI
Primary DI / UDI-DI
05055273208078 FDA UDI
510(k) Number
K092275 FDA UDI
FDA Product Code
DKZ FDA UDI
GMDN Term
Amphetamine/methamphetamine group IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Amphetamine/methamphetamine group IVD, reagent

Mdma by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Amphetamine/methamphetamine group IVD, reagent.

Cleared under the same submission

K092275 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 0e7731bf-284b-4315-a6b3-5fa1b6fa0635 37 fields · synced May 30, 2026