Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Human IgG1 Subclass Bulk Kit (for Siemens BN™II) EUDAMEDHuman 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
- Device Name
- Human IgG1 Subclass Bulk Kit (for Siemens BN™II) EUDAMED
- Model / Reference
- NK006.2TB EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700007559 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051700007559 EUDAMED
- 510(k) Number
- K012292 FDA UDI
- FDA Product Code
- CFN FDA UDI
- EMDN Code
- W0102010106 IMMUNOGLOBULIN G SUBCLASS REAGENTS EUDAMED
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5510 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
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
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
Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit by The Binding Site Group — Class II — IVDD, FDA UDI — listed in FDA GUDID…
Similar devices
Also classified as Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry.
- Alinity — ABBOTT IRELAND · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Alinity — Abbott · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- Dimension® Flex® reagent cartridge IGG — Siemens Healthcare Diagnostics · Class II
- IgG — Randox Laboratories, Ltd. · Class II
- Human IgG4 SPA PLUS Bulk Kit — The Binding Site Group · Class II
- Optilite IgG3 — The Binding Site Group · Class II
Cleared under the same submission
K012292 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI 9bc07eec-d818-4030-b1b2-eb4e24438951 35 fields · synced Jun 19, 2026
- EUDAMED 5002cdf2-d676-4187-80f4-da1f4f259ce0 61 fields · synced Jun 19, 2026