R2458096
R2458096 is a Class II device made by Oxoid Limited, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838026997), 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 | Number00848838026997 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00848838026997
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- R2458096
- Primary DI / UDI-DI
- 00848838026997
- FDA product code
- MHI
- GMDN term
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3220
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MHI (Giardia Spp.).
- PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION by Alexon, Inc.
- GIARDIA/CRYPTOSPORIDIUM QUIK CHEK T30407 by TECHLAB, INC.
- R2450530 by REMEL, INC.
- PROSPECT(TM) GIARDIA RAPID ASSAY by Alexon, Inc.
- UNIGOLD GIARDIA by Trinity Biotech
- GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY by Genzyme Diagnostics
- PREMIER GIARDIA by Meridian Diagnostics, Inc.
- TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) by Trend Scientific, Inc.
- R2450020 by REMEL, INC.