← Back to catalogue

Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
Alinity FDA UDI
Generic Name
Full blood count IVD, calibrator FDA UDI
Device Name
ALINITY h-series HemCal FDA UDI
Model / Reference
04U7302 FDA UDI
Description
ALINITY h-series HemCal FDA UDI

Identifiers

Catalog Number
04U7302 FDA UDI
Primary DI / UDI-DI
00380740151294 FDA UDI
510(k) Number
K020469 FDA UDI
FDA Product Code
KRY FDA UDI
KRX FDA UDI
KSA FDA UDI
KRZ FDA UDI
GMDN Term
Full blood count IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8175 FDA UDI
864.8150 FDA UDI
864.8185 FDA UDI
864.8165 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

No

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: Full blood count IVD, calibrator

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

Similar devices

Also classified as Full blood count IVD, calibrator.

Cleared under the same submission

K020469 also covers:

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

Sources (1)

  • FDA UDI 05a0a78e-185d-4d33-a9e2-ff2d5583edcf 37 fields · synced May 30, 2026