FDA UDI
In Commercial Distribution
🇺🇸 United States
E. HISTOLYTICA II
DI: 00857031002349
·
Model: T5017
·
TECHLAB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- E. HISTOLYTICA II
- Primary DI
- 00857031002349
- Version / Model
- T5017
- Company Name
- TECHLAB, INC.
- Labeler DUNS
- 614218634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 52dd7996-1b6f-4a29-bf02-bc396f675268
Device Description
The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 | 00857031002349 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K994101 | 000 |