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Acrometrix HCV Mid Control

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 963002

by Microgenics Corporation

Identity

Trade Name
Acrometrix HCV Mid Control FDA UDI
Generic Name
Hepatitis C virus antibody/antigen IVD, control FDA UDI
Device Name
Acrometrix HCV Mid Control EUDAMED
Model / Reference
963002 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00884883006461 EUDAMEDFDA UDI
Basic UDI-DI
B-00884883006461 EUDAMED
FDA Product Code
JJX FDA UDI
EMDN Code
W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT EUDAMED
GMDN Term
Hepatitis C virus antibody/antigen IVD, control FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Acrometrix HCV Mid Control by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microgenics Corporation
EUDAMED SRN
US-MF-000030375
Authorised Representative
B·R·A·H·M·S GmbH DE-AR-000026031

Sources (2)

  • EUDAMED 61a9c96a-0cbb-4c89-9634-b712e89bf152 61 fields · synced Jun 19, 2026
  • FDA UDI 591f31ed-7f1c-4015-ae0b-3692d1db039c 32 fields · synced May 30, 2026