EasyScreen™ Sample Processing Kit

Primary DI
09351179000225
Brand
EasyScreen™ Sample Processing Kit
Company
GENETIC SIGNATURES LIMITED
Model
1
Catalog number
SP001
Device description
The EasyScreen™ Sample Processing Kit (SP001) is a kit that contains reagents to isolate, sodium bisulphite treat and purify nucleic acids from clinical specimens or bacterial cultures. The nucleic acids can then be used with compatible EasyScreen™ Detection Kits for various microorganisms.
Published
2024-12-03
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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351179000225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351179000225093511790002259351179000225

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
741249601
Device count
1
Premarket exempt
true
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
09351179000003EasyScreen™ Sample Processing Kit 1SP0122024-11-18
09351179000188EasyScreen™ Sample Processing Kit 1SP008B2024-06-18
09351179001161EasyScreen™ Gastrointestinal Parasite Detection Kit1EP005-HT2024-06-18
09351179004070EasyScreen™ Gastrointestinal Parasite PCR Positive Control1PC-PROT-0012024-06-18