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HairCheck-DT (Opiates)

FDA UDI

Class II (US FDA UDI)

by Quest Diagnostics

Identity

Trade Name
HairCheck-DT (Opiates) FDA UDI
Generic Name
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
HairCheck-DT (Opiates) is an ELISA test kit used for qualitative detection of opiates in head hair with a cutoff of 500 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls. FDA UDI
Model / Reference
K042725 FDA UDI
Description
HairCheck-DT (Opiates) is an ELISA test kit used for qualitative detection of opiates in head hair with a cutoff of 500 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls. FDA UDI

Identifiers

Primary DI / UDI-DI
00868586000223 FDA UDI
FDA Product Code
DJG FDA UDI
GMDN Term
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3650 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

HairCheck-DT (Opiates) by Quest Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quest Diagnostics

Sources (1)

  • FDA UDI 7cfe9435-b253-419d-ba3b-ddb9c2fd81e1 34 fields · synced May 30, 2026