Dimension Flex reagent catridge OXY

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension Flex reagent catridge OXY FDA UDI
Generic Name: Oxycodone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: Urine Oxycodone Screen Flex reagent cartridge, 80 tests FDA UDI
Model / Reference: 11533385 FDA UDI
Description: Urine Oxycodone Screen Flex reagent cartridge, 80 tests FDA UDI

Identifiers

Catalog Number: DF98 FDA UDI
Primary DI / UDI-DI: 00630414287256 FDA UDI
FDA Product Code: DJG FDA UDI
GMDN Term: Oxycodone IVD, kit, enzyme immunoassay (EIA) 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Oxycodone IVD, kit, enzyme immunoassay (EIA)

Dimension Flex reagent catridge OXY by Siemens Healthcare Diagnostics — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI cf8ba4b5-efa2-4d31-be2f-dacc197fca59 36 fields · synced May 30, 2026