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Alinity m

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Alinity m FDA UDI
Generic Name
Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Alinity m HBV AMP Kit FDA UDI
Model / Reference
08N47-095 FDA UDI
Description
Alinity m HBV AMP Kit FDA UDI

Identifiers

Catalog Number
08N47-095 FDA UDI
Primary DI / UDI-DI
00884999047754 FDA UDI
FDA Product Code
MKT FDA UDI
GMDN Term
Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3174 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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 nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Similar devices

Also classified as Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI b780c885-b801-45dc-a062-8f3a459ed5dd 36 fields · synced May 30, 2026