FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]
DI: 08305900070781
·
Model: 7078
·
BIOMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]
- Primary DI
- 08305900070781
- Version / Model
- 7078
- Company Name
- BIOMERICA, INC.
- Labeler DUNS
- 067647321
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-08
- Public Version
- 3
- Public Version Date
- 2021-09-02
- Public Version Status
- Update
- Public Device Record Key
- 6ca1c311-2dd5-47db-80bd-2980c1bf4eb2
- Distribution End Date
- 2020-07-01
Device Description
The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba specific antigen in fecal specimens. This assay is intended for in vitro diagnostic use only.
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | Microbiology | 866.3220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52221 | Entamoeba histolytica antigen 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 antigens from 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 | 08305900070781 | GS1 |
Customer Contacts
- Phone
- +1 949 645 2111
- [email protected]