Here you will find information on these topics:The topics are clickable and lead you directly to the desired information.
I. Conformity according to Medizinproduktegesetz (MPG)
Relation between product groups and Bios reagents. Relation between product groups and EDMS classification.
Download 'Declaration of Conformity' to IVDR 2017/746 for all our tests:
Download of conformity data for our autoantibody assays:
Download of conformity data for our bacteria assays:
Download of conformity data for our viruses assays:
Download of conformity data for our fungi, protozoae and parasites assays:
II. Occupational safety
All in vitro diagnostics available from Bios GmbH Labordiagnostik, München, are designed and manufactured in full compliance with Directive 98/79/EC on in vitro diagnostic medical devices. Our product lines Biognost®, Biosave® and Biosorb® comprise liquid reagents containing sodium azide as a preservative, mostly in a concentration of 0.09%, and in a few products up to 0.1%. Sodium azide is rated as a “dangerous component”. Because the sodium azide level does not exceed 0.1% and our products do not contain any other “dangerous components”, our products are not classified as “dangerous product”.
III. Information and directions for use of BIOS products
A. Method Specific Instructions for Use (Short-version)
Our Instructions for Use have developed from uniform “precursors” and adapted as needed to changing regulatory requirements.
On popular demand, our Bios short-version Instructions for Use are now available to our customers as downloads. In turn, our assay kits will now be delivered to you without the paper copy of the Instructions for Use. This means that you will no longer receive the tri-lingual version of our Instructions for Use that you used to find in each supplied assay kit. The online version is available as monolingual document only. Please let us know if this causes any problems for you.
x = available; o = in revision; no entry = not available in language selected
B. Parameter specific Instructions for Use (Long-version)
Here we provide the long-version Instructions for Use in English and German version as well as other useful data to our customers in a password protected data room.
=> Long-version Instructions for Use (parameter specific).
IV. Photo Gallery of Test results and important staff
=> Photo Gallery of Bios Flower Power and Bios personnel.
=> Photo Gallery of Test results: Fluorescence pattern and other picture of test results
V. Test characteristics - Sensitivity and Specificity of assays of the Biognost® line
What is the value of test results in a medical laboratory?
There is no difference between the importance of a negative and a positive result. Producers and distributors of assays for the medical laboratory can not take off responsibility from appliers to determine selection concerning these assays for their own institute.
Test characteristics which can be verified may help selecting a test system. When increase in quantity of tests performed no longer guarantees success, improvement of quality of single test result could be the alternative.
Documents published here represent data available in the published context from the date of upload. Since quality assurance is elemental part of our business, Bios constantly prepares new data for assay sensitivity and specificity. Thus updates of our published data may vary test characteristics. Visitors of Biosite® should stop by routinely.
And now, how to get to the data of interest?
First choose product group, e.g. bacteria, next choose the parameter of interest, e.g. Bordetella pertussis IgM. If you choose the sensitivity button (you find our Bios emblem on all these buttons) underlying document shows all actual (see publication date) sensitivity data characterizing our Biognost® Bordetella pertussis IgM assay. Want to see other data, please first close document by clicking on the “x” of this tab.
Parasites Fungi Protozoa
VI. Running Times, Longterm Tests
Longterm tests are quality controls, which are run within the running time (interval X), at the end of the running time (interval Y) and after the deterioration date (interval Z) of a lot. Successful LTs may be defined as successful quality controls for the remaining stock of a lot at the end of the running time, which thus converts into a new lot.
Here you'll find our => Long-time data.
On the label of each Bios product the lot number is given. Also lot number(s) is (are) given on Bios delivery notes.
On ordering a kit, assembled from different components with different lots, you may receive on request an analysis certificate listing all these different lot numbers of the different kit components.
Lot numbers unequivocally relate to start of lot production, lots of various components included, other production conditions, QC data and storage data until delivery.
.under construction 21.07.2022
Simple Consideration of errors:
Last modification: 27.7.2022