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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
Alinity FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
Device Name
Alinity i Toxo IgG Calibrators FDA UDI
Model / Reference
07P4504 FDA UDI
Description
Alinity i Toxo IgG Calibrators FDA UDI

Identifiers

Catalog Number
07P4504 FDA UDI
Primary DI / UDI-DI
00380740203177 FDA UDI
510(k) Number
K210596 FDA UDI
FDA Product Code
LGD FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3780 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

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: Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator

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

Similar devices

Also classified as Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator.

Cleared under the same submission

K210596 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI 5d01b9b3-313b-49c0-84ef-c7f499863118 37 fields · synced May 31, 2026