EasyScreen™ Sample Processing Kit
Basic Information
- Brand Name
- EasyScreen™ Sample Processing Kit
- Primary DI
- 09351179000003
- Version / Model
- 1
- Catalog Number
- SP012
- Company Name
- GENETIC SIGNATURES LIMITED
- Labeler DUNS
- 741249601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-18
- Public Version
- 1
- Public Version Date
- 2024-11-26
- Public Version Status
- New
- Public Device Record Key
- ac1df530-8498-447e-9065-4062c9874298
Device Description
The EasyScreen™ Sample Processing Kit (SP012) is designed to rapidly isolate nucleic acids (DNA and RNA) from clinical samples via an automated purification system. Reagents are supplied to convert all nucleic acids into 3base™ sequences and to perform the subsequent purification on supported platforms (Genetic Signatures GS1). The purified nucleic acids are compatible with the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). This kit includes all reagents required to take a sample from the specimen, lyse any microorganisms, convert the nucleic acid into 3base™ form and purify the nucleic acids using magnetic beads. This kit is designed to be used in hospital and pathology laboratories or similar by trained personnel. This kit does not produce any results, but it is a necessary requirement for the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005).
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
- Yes
- 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 |
|---|---|---|---|---|
| 52521 | Nucleic acid extraction/isolation kit IVD | A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09351179000003 | GS1 |
Customer Contacts
- Phone
- +61298707580
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius