← Back to catalogue

Alinity m

FDA UDI

Class N (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Alinity m FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
Alinity m Resp-4-Plex Application Specification File FDA UDI
Model / Reference
09N79-05D FDA UDI
Description
Alinity m Resp-4-Plex Application Specification File FDA UDI

Identifiers

Catalog Number
09N79-05D FDA UDI
Primary DI / UDI-DI
00884999050242 FDA UDI
FDA Product Code
QJR FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
N FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

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

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI 77a28fe9-d0b3-47bb-83be-479855a284ee 35 fields · synced Jun 8, 2026