R2454096
R2454096 is a Class II device made by Oxoid Limited, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838026935), 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 | Number00848838026935 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00848838026935
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- R2454096
- Primary DI / UDI-DI
- 00848838026935
- FDA product code
- MHJ
- GMDN term
- Cryptosporidium species 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 MHJ (Cryptosporidium Spp.).
- IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 by IVD RESEARCH, LLC.
- MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY by Alexon - Trend, Inc.
- R2451020 by REMEL, INC.
- UNI-GOLD CRYPTOSPORIDIUM by Trinity Biotech
- TRI-COMBO PARASITE SCREEN by TECHLAB, INC.
- TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS by Trend Scientific, Inc.
- TRI-COMBO PARASITE SCREEN T30408 by TECHLAB, INC.
- CRYPTOSPORIDIUM ANTIGEN DETECTION by Lmd Laboratories
- PREMIER CRYPTOSPORIDIUM by Meridian Diagnostics, Inc.
- LMD Cryptosporidium Antigen Detection by Lmd Laboratories