EasyScreen™ Sample Processing Kit

EUDAMEDFDA UDI

Class A (EU MDR)

Ref SP012Ref PC-ENT-003Ref SP012.1(CR)

by Genetic Signatures Ltd

Identity

Trade Name: EasyScreen™ Sample Processing Kit EUDAMEDFDA UDI
EasyScreen™ EUDAMED
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: EasyScreen™ Sample Processing Kit EUDAMED
EasyScreen™ Enteric PCR Positive Control EUDAMED
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). FDA UDI
Model / Reference: SP012 EUDAMED
PC-ENT-003 EUDAMED
SP012.1(CR) EUDAMED
1 FDA UDI
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). FDA UDI

Identifiers

Catalog Number: SP012 FDA UDI
Primary DI / UDI-DI: 09351179000003 EUDAMEDFDA UDI
09351179004032 EUDAMED
09351179000096 EUDAMED
Basic UDI-DI: 93511790SP012L7 EUDAMED
B-09351179004032 EUDAMED
EMDN Code: W0105900103 SUPPLEMENTAL NA REAGENTS EUDAMED
W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT EUDAMED
GMDN Term: Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class: Class A EUDAMED
Class IVD General EUDAMED
Market of Registration: Greece EUDAMED
Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

EasyScreen™ Sample Processing Kit by Genetic Signatures Ltd — Class A — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	93511790SP012L7	Class A	Active
EUDAMED	European Union	CE/IVDR	93511790SP012L7	Class A	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class A	Pending data

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Manufacturer

Manufacturer: Genetic Signatures Ltd
EUDAMED SRN: AU-MF-000030901
Authorised Representative: mdi Europa GmbH DE-AR-000006218

Sources (4)

EUDAMED 3a94e6f5-e8b5-4028-acdd-32ec83477f44 61 fields · synced Jul 26, 2026
EUDAMED 6deaa8d1-8dcf-4e2e-9ef2-77d10a201466 61 fields · synced May 18, 2026
EUDAMED 69f5c430-6ea0-44d9-8db2-ea864117ce3a 61 fields · synced May 19, 2026
FDA UDI ac1df530-8498-447e-9065-4062c9874298 36 fields · synced May 30, 2026