FDA.reportPublic FDA data

Genedrive(R)96 SARS-CoV2-kit

Primary DI
05060654860127
Brand
Genedrive(R)96 SARS-CoV2-kit
Company
GENEDRIVE DIAGNOSTICS LTD
Model
1
Catalog number
ID-CoV2-01-FPU
Device description
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 well PCR plated assay and optical film for use on ABI 7500 Fast instrument .
Published
2021-02-19
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
QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid DevicesUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060654860080PackageGS110In Commercial Distribution
05060654860127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060654860080050606548600805060654860080
05060654860127050606548601275060654860127

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18556787768customerservice@provenpharma.com

Regulatory Flags#

DUNS number
239114809
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
05060654860059Genedrive(R)96 SARS-CoV2-kit1ID-CoV2-01-LPU2021-02-19
05060654860103Genedrive(R) 96 SARS CoV2 kit1ID-CoV2-01-BPU2021-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060654860059Genedrive(R)96 SARS-CoV2-kitGENEDRIVE DIAGNOSTICS LTDQLT2021-02-19
05060654860103Genedrive(R) 96 SARS CoV2 kitGENEDRIVE DIAGNOSTICS LTDQLT2021-02-19