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Alinity

FDA UDI

Class N (US FDA UDI)

by Abbott Ireland Diagnostics

Identity

Trade Name
Alinity FDA UDI
Generic Name
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
Device Name
AdviseDx SARS-CoV-2 IgG II Calibrator Kit FDA UDI
Model / Reference
06S6101 FDA UDI
Description
AdviseDx SARS-CoV-2 IgG II Calibrator Kit FDA UDI

Identifiers

Catalog Number
06S6101 FDA UDI
Primary DI / UDI-DI
00380740193805 FDA UDI
FDA Product Code
QKO FDA UDI
GMDN Term
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Alinity by Abbott Ireland Diagnostics — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland Diagnostics

Sources (1)

  • FDA UDI e8e9b7cb-9802-4021-ac13-b17fbc904ced 36 fields · synced May 30, 2026