Identity
- Trade Name
- EasyScreen™ Sample Processing Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- SP001 FDA UDI
- Primary DI / UDI-DI
- 09351179000225 FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
EasyScreen™ Sample Processing Kit by Genetic Signatures Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Genetic Signatures Limited
Sources (1)
- FDA UDI 48551a01-fcfc-4a02-9a2b-9ad577344182 36 fields · synced Jun 1, 2026