Komori
Other Disclosures197ATAUNS Laboratories,Inc.Pharmaceuticals

Notice Regarding Approval for the Manufacture and Sale of the In Vitro Diagnostic "ImmunoAce SARS-CoV-2/Flu II"

The company obtained domestic manufacturing and marketing approval for a new product that can simultaneously test for SARS-CoV-2 and influenza. The product shortens the time to result and extends the shelf life compared with existing products.

Worth reading
57In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
—
Displayed only when the document provides numerical figures.
Wording
Conditional
How definitive the wording is.

Announced details

ImmunoAce SARS-CoV-2/Flu II
Applicable field (uses covered by this announcement)

Antigen testing for SARS-CoV-2 and influenza viruses

What the company reported numerically
Quantitative Effects

Time to result shortened from 15 minutes to 10 minutes. Shelf life extended from 12 months from manufacture to 22 months from manufacture

Registration number and expiry date

Manufacturing and marketing approval number: 30800EZX00026000. Shelf life: 22 months from manufacture

Impact on Business Performance

Currently under review, as the impact will vary depending on the launch timing, sales volume and other factors

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredImmunoAce SARS-CoV-2/Flu II
Applicable areaAntigen testing for SARS-CoV-2 and influenza viruses
Registration number and expiry dateManufacturing and marketing approval number: 30800EZX00026000. Shelf life: 22 months from manufacture
Quantitative EffectsTime to result shortened from 15 minutes to 10 minutes. Shelf life extended from 12 months from manufacture to 22 months from manufacture
Impact on Business PerformanceCurrently under review, as the impact will vary depending on the launch timing, sales volume and other factors
Items this document does not state (13)
CounterpartyCounterparty overviewRelationship with the CompanyContract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyLocationLocation scaleUsage historySource

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The product was developed to improve the time to result and shelf life of existing products. The company will proceed with the procedures required for insurance coverage and preparations for launch.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice Regarding Approval for the Manufacture and Sale of the In Vitro Diagnostic "ImmunoAce SARS-CoV-2/Flu II" | TAUNS Laboratories,Inc. (197A) timely disclosure | Komori