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Doa

FDA UDI

Class U (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
DOA FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, multiplex FDA UDI
Device Name
The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays. FDA UDI
Model / Reference
EV3500 FDA UDI
Description
The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays. FDA UDI

Identifiers

Catalog Number
EV3500 FDA UDI
Primary DI / UDI-DI
05055273202137 FDA UDI
510(k) Number
K030360 FDA UDI
K040350 FDA UDI
K040570 FDA UDI
K041142 FDA UDI
K041143 FDA UDI
K041144 FDA UDI
K043071 FDA UDI
K050179 FDA UDI
FDA Product Code
LCM FDA UDI
DJG FDA UDI
LDJ FDA UDI
JXM FDA UDI
DIS FDA UDI
DKZ FDA UDI
DJR FDA UDI
DIO FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, multiplex FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3650 FDA UDI
862.3870 FDA UDI
862.3170 FDA UDI
862.3150 FDA UDI
862.3100 FDA UDI
862.3620 FDA UDI
862.3250 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: Multiple drugs of abuse IVD, kit, multiplex

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

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, multiplex.

Cleared under the same submission

K030360 also covers:

K040350 also covers:

K040570 also covers:

K041142 also covers:

K041143 also covers:

K041144 also covers:

K043071 also covers:

K050179 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 0ca14a85-7068-45a7-abb5-fc5e4c930bbb 37 fields · synced Jun 1, 2026