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First Sign®

FDA UDI

Class II (US FDA UDI)

by Hemosure Inc.

Identity

Trade Name
First Sign® FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure, CLIA Waived EDDP FDA UDI
Model / Reference
FSCDIPED-25 FDA UDI
Description
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure, CLIA Waived EDDP FDA UDI

Identifiers

Primary DI / UDI-DI
00817763022060 FDA UDI
FDA Product Code
DJR FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3620 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

Yes

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, rapid ICT, clinical

First Sign® by Hemosure Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hemosure Inc.

Sources (1)

  • FDA UDI b2a000f1-3a29-4561-a077-60d28ad1ec5b 33 fields · synced May 30, 2026