FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyScreen™ Sample Processing Kit
DI: 09351179000225
·
Model: 1
·
GENETIC SIGNATURES LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EasyScreen™ Sample Processing Kit
- Primary DI
- 09351179000225
- Version / Model
- 1
- Catalog Number
- SP001
- Company Name
- GENETIC SIGNATURES LIMITED
- Labeler DUNS
- 741249601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-03
- Public Version
- 1
- Public Version Date
- 2024-12-11
- Public Version Status
- New
- Public Device Record Key
- 48551a01-fcfc-4a02-9a2b-9ad577344182
Device Description
The EasyScreen™ Sample Processing Kit (SP001) is a kit that contains reagents to isolate, sodium bisulphite treat and purify nucleic acids from clinical specimens or bacterial cultures. The nucleic acids can then be used with compatible EasyScreen™ Detection Kits for various microorganisms.
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 | 09351179000225 | GS1 |
Customer Contacts
- Phone
- +61298707580
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius