FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyScreen™ Gastrointestinal Parasite Detection Kit
DI: 09351179001161
·
Model: 1
·
GENETIC SIGNATURES LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EasyScreen™ Gastrointestinal Parasite Detection Kit
- Primary DI
- 09351179001161
- Version / Model
- 1
- Catalog Number
- EP005-HT
- Company Name
- GENETIC SIGNATURES LIMITED
- Labeler DUNS
- 741249601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-18
- Public Version
- 1
- Public Version Date
- 2024-06-26
- Public Version Status
- New
- Public Device Record Key
- 765c6820-4711-413d-bb34-8f7f9180b620
Device Description
The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64636 | Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple faecal parasites (e.g., Giardia, Entamoeba, Cryptosporidium, Dientamoeba species) in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09351179001161 | GS1 |
Customer Contacts
- Phone
- +61298707580
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232672 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius