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DRI Methaqualone Assay

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0515

by Microgenics Corporation

Identity

Trade Name
DRI Methaqualone Assay FDA UDI
Generic Name
Methaqualone IVD, kit, radioimmunoassay FDA UDI
Device Name
DRI Methaqualone Assay EUDAMED
Model / Reference
0515 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00884883002937 EUDAMEDFDA UDI
Basic UDI-DI
B-00884883002937 EUDAMED
510(k) Number
K940123 FDA UDI
FDA Product Code
KXS FDA UDI
EMDN Code
W0102090111 METHAQUALONE EUDAMED
GMDN Term
Methaqualone IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.3630 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

DRI Methaqualone Assay by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microgenics Corporation
EUDAMED SRN
US-MF-000030375
Authorised Representative
B·R·A·H·M·S GmbH DE-AR-000026031

Sources (2)

  • EUDAMED ee684ea5-1fb9-4442-aa32-3fa03a5fff60 61 fields · synced Jul 31, 2026
  • FDA UDI 7fa5b5df-fedb-48d7-952a-97a4cdb9ea08 33 fields · synced May 30, 2026