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Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800 FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK009.IM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700006224 FDA UDI
- 510(k) Number
- K000701 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 IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800 by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID
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 II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI 2ca12087-93f8-4319-b4c5-f1f0a7b9fe44 36 fields · synced May 30, 2026