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Multichem ID HAV IgM Positive Control
EUDAMEDFDA UDIClass B (EU MDR)
Ref 2015-0337Model Multichem ID HAV IgM Positive Control
Identity
- Trade Name
- Multichem ID HAV IgM Positive Control EUDAMEDMULTICHEM FDA UDI
- Generic Name
- Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Model / Reference
- Multichem ID HAV IgM Positive Control EUDAMED2015-0337 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850041090900 EUDAMEDFDA UDI
- Basic UDI-DI
- 0816784020081Y3 EUDAMED
- EMDN Code
- W0105080802 HEPATITIS VIRUS CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
New Device
Yes
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Multichem ID HAV IgM Positive Control by LGC Clinical Diagnostics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0816784020081Y3 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 150f2bdc-f522-4b94-9ee8-1591156e3f45 61 fields · synced Jul 10, 2026
- FDA UDI 69d61051-c356-4b29-a089-7b2ab04612f2 32 fields · synced May 30, 2026