FDA.reportPublic FDA data

EasyScreen™ Gastrointestinal Parasite PCR Positive Control

Primary DI
09351179004070
Brand
EasyScreen™ Gastrointestinal Parasite PCR Positive Control
Company
GENETIC SIGNATURES LIMITED
Model
1
Catalog number
PC-PROT-001
Device 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.
Published
2024-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232672000EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited2024-05-29PCH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351179004070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351179004070093511790040709351179004070

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type gastrointestinal pathogen nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative and/or qualitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61298707580northamerica@geneticsignatures.com

Regulatory Flags#

DUNS number
741249601
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351179000225EasyScreen™ Sample Processing Kit 1SP0012024-12-03
09351179000003EasyScreen™ Sample Processing Kit 1SP0122024-11-18
09351179000188EasyScreen™ Sample Processing Kit 1SP008B2024-06-18
09351179001161EasyScreen™ Gastrointestinal Parasite Detection Kit1EP005-HT2024-06-18

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