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Alinity m

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Alinity m FDA UDI
Generic Name
General-purpose absorbent tip applicator/swab, single-use FDA UDI
Model / Reference
09N19-012 FDA UDI

Identifiers

Catalog Number
09N19-012 FDA UDI
Primary DI / UDI-DI
00884999048898 FDA UDI
510(k) Number
K202977 FDA UDI
FDA Product Code
OOI FDA UDI
LSL FDA UDI
MKZ FDA UDI
OUY FDA UDI
QEP FDA UDI
GMDN Term
General-purpose absorbent tip applicator/swab, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3390 FDA UDI
866.3120 FDA UDI
866.3860 FDA UDI
866.3393 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: General-purpose absorbent tip applicator/swab, single-useGeneral specimen container IVD, no additive/medium

Alinity m by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Cleared under the same submission

K202977 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI b2a36e8b-60de-4c4a-94ea-a8f74a105c13 36 fields · synced May 30, 2026