R2456096
R2456096 is a Class II device made by Oxoid Limited, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838026966), 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 | Number00848838026966 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00848838026966
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- R2456096
- Primary DI / UDI-DI
- 00848838026966
- FDA product code
- GMD
- GMDN term
- Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3165
- GUDID distribution status
- In Commercial Distribution
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- Cryptococcus Neoformans Antiserum, Latex by Meridian Diagnostics, Inc.
- CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM by I M, Inc.
- CRYPTO-LEX SYSTEM by Trinity Laboratories, Inc.