Alinity m

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name: Alinity m FDA UDI
Generic Name: Assay container IVD, single-use FDA UDI
Device Name: Alinity m Bottle for Ethanol Use FDA UDI
Model / Reference: 09N20-012 FDA UDI
Description: Alinity m Bottle for Ethanol Use FDA UDI

Identifiers

Catalog Number: 09N20-012 FDA UDI
Primary DI / UDI-DI: 00884999049314 FDA UDI
FDA Product Code: MKZ FDA UDI
QEP FDA UDI
OUY FDA UDI
OOI FDA UDI
LSL FDA UDI
GMDN Term: Assay container IVD, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.3120 FDA UDI
866.3393 FDA UDI
866.3860 FDA UDI
862.2570 FDA UDI
866.3390 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Assay container IVD, single-use

Alinity m by Abbott Molecular — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Abbott Molecular

Sources (1)

FDA UDI 990bfb2d-8e26-45dc-baa6-bb3a371daf56 36 fields · synced May 31, 2026