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EUDAMED last updated this device on Jun 25, 2024
B-06438172401013NeoMass CAH is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Labsystems Diagnostics Oy. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
064381724010137150022(01)06438172401013
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102060699MULTIPLE INDIVIDUAL HORMONES - OTHER12 warnings recorded — scroll inside the panel to see all entries.
POTENTIAL BIOHAZARDOUS MATERIAL: All human materials used in the preparation of the calibrators/controls in the kit have been tested for the presence of the antibodies to HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) as well as Hepatitis B surface antigen (HBsAg) and found to be non-reactive. Because no test method can offer complete assurance that HIV, HBV, HCV, or other infectious agents are absent, these calibrators and controls as well as samples should be handled at the Biosafety level 2 as recommended for any potentially infectious human serum or blood sample in the Centers for Disease Control and prevention/National Institutes for Health Manual, “Biosafety in Microbiological and Biomedical Laboratories”, 5th Ed. 2009. Discard all materials and samples as if capable of transmitting infection. The preferred method of disposal is autoclaving for a minimum of one hour at 121°C. Liquid wastes not containing acid and neutralized waste may be mixed with sodium hypochlorite in volumes such that the final mixture contains 50-500 mg/l free available chlorine. Allow 30 minutes for decontamination to be completed. Spills should be wiped off thoroughly using either an iodophor disinfectant or sodium hypochlorite solution. Materials used to wipe off spills should be added to biohazardous waste matter for proper disposal. Reusable glassware must be disinfected, washed out and rinsed free of detergents. Avoid contact with skin and eyes when handling extraction and elution solutions. Wear disposable gloves while handling samples and kit reagents. Afterwards wash hands carefully. Never pipette by mouth. Do not interchange reagents or vial caps. Once the assay has been started, all subsequent steps should be performed without interruption. Strict adherence to the protocol is advised to obtain reliable results. Any modification or change made to the kit or the assay procedures are under the responsibility of the user.
Primary placement in Finland; available across 1 country total.
Placed on the market in Finland; per-country availability dates not published.
FI-MF-000018281Highly flammable liquid and vapour.
Flammable liquid and vapour
Harmful if swallowed, in contact with skin or if inhaled
Toxic if swallowed, in contact with skin or if inhaled.
Causes skin irritation.
May cause an allergic skin reaction.
Causes serious eye irritation
May cause respiratory irritation.
Suspected of causing cancer.
May damage fertility of unborn child
Causes damage to organs.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-06438172403062On the marketNeoMass AAAC Plus Internal Standard - Labelled Succinylacetone (ISTD - SUAC)B-06438172403055On the marketNeoMass AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA)B-06438172403031On the marketNeoMass CAH Extraction Solution with Internal StandardB-06438172401044On the marketNeoMass CAH Mobile Phase AB-06438172401068On the marketNeoMass CAH Mobile Phase BB-06438172401075On the market