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EasyScreen™ Gastrointestinal Parasite PCR Positive Control

FDA UDI

Class II (US FDA UDI)

by Genetic Signatures Limited

Identity

Trade Name
EasyScreen™ Gastrointestinal Parasite PCR Positive Control FDA UDI
Generic Name
Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI
Device Name
The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel. FDA UDI
Model / Reference
1 FDA UDI
Description
The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel. FDA UDI

Identifiers

Catalog Number
PC-PROT-001 FDA UDI
Primary DI / UDI-DI
09351179004070 FDA UDI
510(k) Number
K232672 FDA UDI
FDA Product Code
PCH FDA UDI
OOI FDA UDI
GMDN Term
Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3990 FDA UDI
862.2570 FDA UDI
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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple-type gastrointestinal pathogen nucleic acid IVD, control

EasyScreen™ Gastrointestinal Parasite PCR Positive Control by Genetic Signatures Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genetic Signatures Limited

Sources (1)

  • FDA UDI 089bf7d6-34d6-4646-9535-2619499bd5bb 37 fields · synced Jun 1, 2026