EasyScreen™ Sample Processing Kit

FDA UDIEUDAMED

by Genetic Signatures Limited

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 (SP008B) 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: 1 FDA UDI
Description: The EasyScreen™ Sample Processing Kit (SP008B) 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: SP008B FDA UDI
Primary DI / UDI-DI: 09351179000188 FDA UDI
GMDN Term: Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

Category: Nucleic acid extraction/isolation kit IVD

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

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Also classified as Nucleic acid extraction/isolation kit IVD.

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VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
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Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	N/A	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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Manufacturer

Manufacturer: Genetic Signatures Limited

Sources (2)

FDA UDI bcd947a7-9ffb-4c23-a3dd-ed3ed8b38476 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 2, 2026