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Atellica IM aHAVM

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM aHAVM FDA UDI
Generic Name
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T FDA UDI
Model / Reference
10995444 FDA UDI
Description
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T FDA UDI

Identifiers

Catalog Number
10995444 FDA UDI
Primary DI / UDI-DI
00630414597737 FDA UDI
PMA Number
P040018 FDA UDI
510(k) Number
K081716 FDA UDI
FDA Product Code
LOL FDA UDI
GMDN Term
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3310 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

No

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: Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM aHAVM by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K081716 also covers:

P040018 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 91123bc9-69f5-4bb8-91b2-ba814900a7c3 37 fields · synced May 31, 2026