← Back to catalogue
Multichem ID Multi-Marker Negative Control 2 x 4mL
EUDAMEDFDA UDIClass B (EU MDR)
Ref 2010-0260Model Multichem ID Multi-Marker Negative Control 2 x 4mL
Identity
- Trade Name
- Multichem ID Multi-Marker Negative Control 2 x 4mL EUDAMEDMULTICHEM FDA UDI
- Generic Name
- Negative control immunoglobulin IVD FDA UDI
- Model / Reference
- Multichem ID Multi-Marker Negative Control 2 x 4mL EUDAMED2010-0260 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850041090917 EUDAMEDFDA UDI
- Basic UDI-DI
- 0816784020080XZ EUDAMED
- EMDN Code
- W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
- GMDN Term
- Negative control immunoglobulin IVD 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
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 Multi-Marker Negative Control 2 x 4mL by LGC Clinical Diagnostics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0816784020080XZ | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED b0e31557-4584-4ede-867f-674ebe462958 61 fields · synced Jul 23, 2026
- FDA UDI 79d936fd-364a-4b82-868f-97ed61cdf85b 32 fields · synced May 30, 2026