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Doa Cal

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: DOA CAL FDA UDI
Generic Name: Multiple drugs of abuse IVD, calibrator FDA UDI
Device Name: Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. FDA UDI
Model / Reference: EV3550 FDA UDI
Description: Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. FDA UDI

Identifiers

Catalog Number: EV3550 FDA UDI
Primary DI / UDI-DI: 05055273202458 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: DKB FDA UDI
GMDN Term: Multiple drugs of abuse IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3200 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, calibrator

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

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Cleared under the same submission

K030360 also covers:

K040350 also covers:

DOA — Randox Laboratories, Ltd.
DOA — Randox Laboratories, Ltd.

K040570 also covers:

DOA — Randox Laboratories, Ltd.
DOA — Randox Laboratories, Ltd.

K041142 also covers:

DOA — Randox Laboratories, Ltd.
DOA — Randox Laboratories, Ltd.

K041143 also covers:

DOA — Randox Laboratories, Ltd.
DOA — Randox Laboratories, Ltd.

K041144 also covers:

DOA — Randox Laboratories, Ltd.
DOA — Randox Laboratories, Ltd.

K043071 also covers:

DOA — Randox Laboratories, Ltd.
DOA — Randox Laboratories, Ltd.

K050179 also covers:

DOA — Randox Laboratories, Ltd.
DOA — Randox Laboratories, Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI f7e46e86-0913-4409-beea-f68a3d8d8fb7 37 fields · synced May 31, 2026