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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
Alinity FDA UDI
Generic Name
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Alinity i Anti-HBc IgM Reagent Kit 200 Tests FDA UDI
Model / Reference
07P8621 FDA UDI
Description
Alinity i Anti-HBc IgM Reagent Kit 200 Tests FDA UDI

Identifiers

Catalog Number
07P8621 FDA UDI
Primary DI / UDI-DI
00380740130282 FDA UDI
PMA Number
P060035 FDA UDI
FDA Product Code
LOM FDA UDI
GMDN Term
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3172 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: Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

P060035 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 8bc7fb82-7cc2-4413-9207-74bc536e1794 37 fields · synced Jun 8, 2026