R2458496
R2458496 is a Class II device made by Oxoid Limited, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838027000), 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 | Number00848838027000 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00848838027000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- R2458496
- Primary DI / UDI-DI
- 00848838027000
- FDA product code
- MHI
- GMDN term
- Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3220
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code MHI (Giardia Spp.).
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- R2450020 by REMEL, INC.
- GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK by Techlab Inc., Corporate Research Center
- MODIFICATION PROSPECT GIARDIA RAPID ASSAY by Alexon, Inc.
- GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF by IVD RESEARCH, LLC.
- CRYPTO/GIARDIA-CEL IF TEST by TECHLAB, INC.