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PharmChek (R) Drugs of Abuse Sweat Patch

FDA UDI

Class I (US FDA UDI)

by Pharmchem, Inc.

Identity

Trade Name
PharmChek (R) Drugs of Abuse Sweat Patch FDA UDI
Generic Name
Drug-testing specimen collection kit IVD FDA UDI
Device Name
PharmChek® is a drug sweat patch worn on the skin surface for up to 10 days or longer that acts as a specimen container for the non-volatile and liquid components of sweat. FDA UDI
Model / Reference
Single Patch FDA UDI
Description
PharmChek® is a drug sweat patch worn on the skin surface for up to 10 days or longer that acts as a specimen container for the non-volatile and liquid components of sweat. FDA UDI

Identifiers

Primary DI / UDI-DI
00860001701005 FDA UDI
FDA Product Code
FMH FDA UDI
GMDN Term
Drug-testing specimen collection kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Drug-testing specimen collection kit IVD

PharmChek (R) Drugs of Abuse Sweat Patch by Pharmchem, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drug-testing specimen collection kit IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pharmchem, Inc.

Sources (1)

  • FDA UDI 581a6ae6-5c1b-4749-8430-0edfdf668e69 35 fields · synced Jun 6, 2026