Genedrive(R)96 SARS-CoV2-kit ID-CoV2-01-FPU

GUDID 05060654860127

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 .

GENEDRIVE DIAGNOSTICS LTD

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 05060654860127
• NIH Device Record Key: 34b5d1c6-9e4e-4358-8998-e4d4f6fd5285
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genedrive(R)96 SARS-CoV2-kit
• Version Model Number: 1
• Catalog Number: ID-CoV2-01-FPU
• Company DUNS: 239114809
• Company Name: GENEDRIVE DIAGNOSTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com
• Phone: +18556787768
• Email: customerservice@provenpharma.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060654860080 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	05060654860127 [Primary]

FDA Product Code

• QLT: Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-01
• Device Publish Date: 2021-02-19

On-Brand Devices [Genedrive(R)96 SARS-CoV2-kit]

• 05060654860127: Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 wel
• 05060654860059: Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well