FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RIDASCREEN® Entamoeba histolytica IgG
DI: 04049095110023
·
Model: K1721
·
R-Biopharm AG
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RIDASCREEN® Entamoeba histolytica IgG
- Primary DI
- 04049095110023
- Version / Model
- K1721
- Catalog Number
- K1721
- Company Name
- R-Biopharm AG
- Labeler DUNS
- 321850323
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-08
- Public Version
- 3
- Public Version Date
- 2023-06-13
- Public Version Status
- Update
- Public Device Record Key
- 49466845-dd94-48b8-a06c-b6728b8c5009
- Distribution End Date
- 2022-12-31
Device Description
The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Entamoeba histolytica in human serum. The test should be used for confirmation purposes when there is a suspected case of amoebiasis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52225 | Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Entamoeba histolytica in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049095110023 | GS1 |