N Latex IgG4
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- N Latex IgG4 EUDAMEDFDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
- Device Name
- IVDR_27_MAR EB_B_REAG_N_La_IGG4 EUDAMEDQuantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems FDA UDI
- Model / Reference
- 10445971 EUDAMEDFDA UDIIVDR_27_MAR EB_B_REAG_N_La_IGG4 EUDAMED
- Description
- Quantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems FDA UDI
Identifiers
- Catalog Number
- OPAU03 FDA UDI
- Primary DI / UDI-DI
- 00842768006692 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900884WB EUDAMED
- FDA Product Code
- DAS FDA UDI
- EMDN Code
- W0102010106 IMMUNOGLOBULIN G SUBCLASS REAGENTS EUDAMED
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5530 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunoglobulin G subclass (IgG subclass) IVD, reagent
N Latex IgG4 by Siemens Healthcare Diagnostics Products Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI 425d205a-a4d3-480a-a3d8-edc929f5f357 36 fields · synced Jul 8, 2026
- EUDAMED c1e1b8fa-9a3f-46af-8312-57001f5f4dae 61 fields · synced Jul 8, 2026