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Acrometrix HCV High Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 963003
Identity
- Trade Name
- Acrometrix HCV High Control FDA UDI
- Generic Name
- Hepatitis C virus antibody/antigen IVD, control FDA UDI
- Device Name
- Acrometrix HCV High Control EUDAMED
- Model / Reference
- 963003 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883006539 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883006539 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 EUDAMEDClass 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 High 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883006539 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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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 cdc521d4-4ba7-468b-b080-a7d3b29898b8 61 fields · synced Jul 15, 2026
- FDA UDI f35b62f6-a092-49a7-9c2e-6e44ff25582a 32 fields · synced May 30, 2026