Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK007.2TB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700007641 FDA UDI
- 510(k) Number
- K012292 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
For the Siemens BN™II - Bulk Kit, our Human IgG2 Subclass Liquid Reagent Kit for use provides precise and accurate measurements of Immunoglobulin G subclasses in clinical specimens. This reagent kit is designed to meet the high standards of medical professionals and researchers, ensuring reliable results in a variety of applications.
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Cleared under the same submission
K012292 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI a14f5d0c-0608-45c6-8346-bd318b0b1d15 35 fields · synced Jul 31, 2026