Primary Device ID | 05060654860103 |
NIH Device Record Key | 1b57f101-c7db-4a68-a4d9-70cd51999b14 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Genedrive(R) 96 SARS CoV2 kit |
Version Model Number | 1 |
Catalog Number | ID-CoV2-01-BPU |
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 |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com | |
Phone | +1-855-678-7768 |
customerservice@provenpharma.com |
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 Issuing Agency | Device ID |
---|---|
GS1 | 05060654860103 [Primary] |
GS1 | 05060654860110 [Package] Package: Box [10 Units] In Commercial Distribution |
QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-03-01 |
Device Publish Date | 2021-02-19 |
05060654860059 - Genedrive(R)96 SARS-CoV2-kit | 2021-03-01 Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical fil |
05060654860103 - Genedrive(R) 96 SARS CoV2 kit | 2021-03-01Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument. |
05060654860103 - Genedrive(R) 96 SARS CoV2 kit | 2021-03-01 Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical fil |
05060654860127 - Genedrive(R)96 SARS-CoV2-kit | 2021-03-01 Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 well PCR plated assay and optical f |