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Atellica™ IM aHCV QC

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica™ IM aHCV QC FDA UDI
Generic Name
Hepatitis C virus total antibody IVD, control FDA UDI
Device Name
HCV (aHCV) QC Kit - Atellica IM - CLT 2 x 2 x 7.0 mL FDA UDI
Model / Reference
10995457 FDA UDI
Description
HCV (aHCV) QC Kit - Atellica IM - CLT 2 x 2 x 7.0 mL FDA UDI

Identifiers

Catalog Number
10995457 FDA UDI
Primary DI / UDI-DI
00630414597874 FDA UDI
FDA Product Code
MZO FDA UDI
GMDN Term
Hepatitis C virus total antibody IVD, control 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

Yes

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 C virus total antibody IVD, control

Atellica™ IM aHCV QC 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, control.

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 eaa2776f-8b78-4efd-b99a-9a2744375438 36 fields · synced May 30, 2026