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ARK™ Efavirenz Assay

FDA UDI

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Efavirenz Assay FDA UDI
Generic Name
Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ARK™ Efavirenz Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of efavirenz in human serum or plasma on automated clinical chemistry analyzers. FDA UDI
Model / Reference
5017-0001-00 FDA UDI
Description
The ARK™ Efavirenz Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of efavirenz in human serum or plasma on automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number
5017-0001-00 FDA UDI
Primary DI / UDI-DI
00858724003377 FDA UDI
GMDN Term
Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

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-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ARK™ Efavirenz Assay by Ark Diagnostics Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ark Diagnostics Inc

Sources (1)

  • FDA UDI 3b78de1f-46f2-471e-b25c-da2c70e1b4d2 36 fields · synced May 31, 2026