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Alinity

FDA UDI

by Abbott

Identity

Trade Name
Alinity FDA UDI
Generic Name
Hepatitis B virus core total antibody IVD, calibrator FDA UDI
Device Name
Alinity s Anti-HBc Calibrator Kit FDA UDI
Model / Reference
06P0603 FDA UDI
Description
Alinity s Anti-HBc Calibrator Kit FDA UDI

Identifiers

Catalog Number
06P0603 FDA UDI
Primary DI / UDI-DI
00380740167455 FDA UDI
GMDN Term
Hepatitis B virus core total antibody IVD, calibrator FDA UDI

Classification

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

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: Hepatitis B virus core total antibody IVD, calibrator

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

Similar devices

Also classified as Hepatitis B virus core total antibody IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI ea012687-7db8-4a4b-804d-71dbe4481c3e 36 fields · synced Jun 1, 2026