← Back to catalogue

Alinity

FDA UDI

Class I (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
Alinity FDA UDI
Generic Name
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry FDA UDI
Device Name
Alinity c UIBC Reagent Kit 300 Tests FDA UDI
Model / Reference
08P4420 FDA UDI
Description
Alinity c UIBC Reagent Kit 300 Tests FDA UDI

Identifiers

Catalog Number
08P4420 FDA UDI
Primary DI / UDI-DI
00380740121891 FDA UDI
FDA Product Code
JQF FDA UDI
GMDN Term
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1415 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: Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

Alinity by Abbott Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry.

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 Laboratories, Inc.

Sources (1)

  • FDA UDI 48871f91-a6e6-46c4-bc90-02e3d042c818 36 fields · synced May 30, 2026