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Human IgG1 Subclass Liquid Reagent Kit for use on the Siemens BN™II Analyser
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Human IgG1 Subclass Liquid Reagent Kit for use on the Siemens BN™II Analyser FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK006.T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700007627 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Human IgG1 Subclass Liquid Reagent Kit for use on the Siemens BN™II Analyser by The Binding Site Group — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI 5a9dc9e1-53f2-4f9e-b2f9-e3a5a8e18c21 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026