Rapid ONE

FDA UDI

Class U (US FDA UDI)

by American Bio Medica Corp.

Identity

Trade Name: Rapid ONE FDA UDI
Generic Name: Opiate/opiate metabolite IVD, calibrator FDA UDI
Device Name: Opi 300 pouched strip 100/box FDA UDI
Model / Reference: 10-OPIS-000 FDA UDI
Description: Opi 300 pouched strip 100/box FDA UDI

Identifiers

Catalog Number: 10-OPIS-000 FDA UDI
Primary DI / UDI-DI: 10694644800026 FDA UDI
FDA Product Code: LCM FDA UDI
LFG FDA UDI
LDJ FDA UDI
JXN FDA UDI
DJG FDA UDI
DJR FDA UDI
DJC FDA UDI
DIO FDA UDI
JXM FDA UDI
DIS FDA UDI
DKG FDA UDI
GMDN Term: Opiate/opiate metabolite IVD, calibrator FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 862.3910 FDA UDI
862.3870 FDA UDI
862.3700 FDA UDI
862.3650 FDA UDI
862.3620 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
862.3150 FDA UDI
862.2270 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Opiate/opiate metabolite IVD, calibrator

Rapid ONE by American Bio Medica Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: American Bio Medica Corp.

Sources (1)

FDA UDI 4946989a-b23a-4ae1-b203-be0dc97b6218 36 fields · synced May 30, 2026