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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
Morphine/morphine metabolite IVD, kit, rapid ICT, clinical FDA UDI
Device Name
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure OPI FDA UDI
Model / Reference
FSCWOP-25 FDA UDI
Description
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure OPI FDA UDI

Identifiers

Catalog Number
FSCWOP-25 FDA UDI
Primary DI / UDI-DI
00857338006569 FDA UDI
FDA Product Code
DJG FDA UDI
GMDN Term
Morphine/morphine metabolite IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3650 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: Morphine/morphine metabolite 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 Morphine/morphine metabolite 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 c5730308-31dd-46b4-ab65-c053afc94fd6 34 fields · synced May 30, 2026