N Antiserum to Human C4
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- N Antiserum to Human C4 EUDAMEDFDA UDI
- Generic Name
- Complement components C4/C4c IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- IVDR_27_MAR EB_B_REAG_N_AS_C4 EUDAMEDQuantitative determination of complement C4 in human serum and plasma on BN Systems FDA UDI
- Model / Reference
- 10446289 EUDAMEDFDA UDIIVDR_27_MAR EB_B_REAG_N_AS_C4 EUDAMED10446288 FDA UDI
- Description
- Quantitative determination of complement C4 in human serum and plasma on BN Systems FDA UDI
Identifiers
- Catalog Number
- OSAO09 FDA UDIOSAO15 FDA UDI
- Primary DI / UDI-DI
- 00842768009709 EUDAMEDFDA UDI00842768009693 FDA UDI
- Basic UDI-DI
- 0405686900980W8 EUDAMED
- 510(k) Number
- K050665 FDA UDI
- FDA Product Code
- DBI FDA UDI
- EMDN Code
- W0102010205 COMPLEMENT COMPONENT C4 EUDAMED
- GMDN Term
- Complement components C4/C4c IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
N Antiserum to Human C4 by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Complement components C4/C4c IVD, kit, nephelometry/turbidimetry.
- Atellica CH C4 — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott · Class II
- Dimension® Flex® reagent cartridge C4 — Siemens Healthcare Diagnostics · Class II
- Tinaquant Complement C4 ver2 — Roche Diagnostics Corp. · Class II
- Tinaquant C4 — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ADVIA® Chemistry C4 Complement C4 Reagents — Siemens Healthcare Diagnostics · Class II
- Tinaquant Complement C4 ver2 — Roche Diagnostics Corp. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (3)
- FDA UDI 62b790bc-53da-4571-9627-6b4623a02333 37 fields · synced Jul 8, 2026
- FDA UDI 21a268a3-76cc-4d0f-92f1-6163d8bdb1e6 37 fields · synced May 30, 2026
- EUDAMED 9c8c25ea-389a-411a-a28d-5bbd7c10751c 61 fields · synced Jul 8, 2026