EasyScreen™ Gastrointestinal Parasite Detection Kit

Primary DI
09351179001161
Brand
EasyScreen™ Gastrointestinal Parasite Detection Kit
Company
GENETIC SIGNATURES LIMITED
Model
1
Catalog number
EP005-HT
Device description
The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea.
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#

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
09351179001161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351179001161093511790011619351179001161

GMDN Terms#

Term, Definition table
TermDefinition
Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple faecal parasites (e.g., Giardia, Entamoeba, Cryptosporidium, Dientamoeba species) in a clinical specimen, using a nucleic acid technique (NAT).

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
09351179004070EasyScreen™ Gastrointestinal Parasite PCR Positive Control1PC-PROT-0012024-06-18