Identity
- Trade Name
- N Latex IgG3 FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
- Device Name
- Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems FDA UDI
- Model / Reference
- 10445972 FDA UDI
- Description
- Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems FDA UDI
Identifiers
- Catalog Number
- OPAV03 FDA UDI
- Primary DI / UDI-DI
- 00842768006708 FDA UDI
- FDA Product Code
- DAS FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Immunoglobulin G subclass (IgG subclass) IVD, reagent
N Latex IgG3 by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- N Latex IgG4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI c57f1fd0-df79-42c3-b485-fc3b3b5eee96 36 fields · synced Jun 6, 2026