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Atellica™ IM aHCV

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica™ IM aHCV FDA UDI
Generic Name
Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI
Device Name
HCV (aHCV) - Atellica IM - RGT - 200T FDA UDI
Model / Reference
10995456 FDA UDI
Description
HCV (aHCV) - Atellica IM - RGT - 200T FDA UDI

Identifiers

Catalog Number
10995456 FDA UDI
Primary DI / UDI-DI
00630414597867 FDA UDI
PMA Number
P030056 FDA UDI
FDA Product Code
MZO FDA UDI
GMDN Term
Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3169 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

Yes

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 C virus total antibody IVD, kit, chemiluminescent assay

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

Similar devices

Also classified as Hepatitis C virus total antibody IVD, kit, chemiluminescent assay.

Cleared under the same submission

P030056 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 6f9a2230-55be-4751-ab9f-84811dac6698 37 fields · synced May 31, 2026