IgD AMR Fluid BP506
IgD AMR Fluid BP506 is a Class I device made by The Binding Site Group, listed in FDA GUDID since 7 Jun 2023 (UDI-DI 05051700015974), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05051700015974 | Date7 Jun 2023 | StatusListed |
Official records
- AccessGUDID record 05051700015974
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- IgD AMR Fluid
- Generic name
- Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
- Model / reference
- BP506
- Primary DI / UDI-DI
- 05051700015974
- FDA product code
- JJX
- GMDN term
- Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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