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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
Cytomegalovirus (CMV) nucleic acid IVD, calibrator FDA UDI
Device Name
Alinity m CMV CAL Kit FDA UDI
Model / Reference
09N46-075 FDA UDI
Description
Alinity m CMV CAL Kit FDA UDI

Identifiers

Catalog Number
09N46-075 FDA UDI
Primary DI / UDI-DI
00884999049598 FDA UDI
PMA Number
P210022 FDA UDI
FDA Product Code
PAB FDA UDI
GMDN Term
Cytomegalovirus (CMV) nucleic acid IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3180 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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: Cytomegalovirus (CMV) nucleic acid IVD, calibrator

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

Similar devices

Also classified as Cytomegalovirus (CMV) nucleic acid IVD, calibrator.

Cleared under the same submission

P210022 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 28db1177-e9bb-481b-807d-cb217ada3f2a 37 fields · synced Jun 1, 2026