- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Apr 21, 2026
084535708247BG[8247] QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Microbiologics, INC.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
70845357043619[8247] QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)(01)70845357043619
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105080807MULTICONSTITUENT CONTROLS - INF.IMM.1 warning recorded — scroll inside the panel to see all entries.
CW011US-MF-000000466The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
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 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.0845357001208XOn the market[0832K] KWIK-STIK™ S. aureus ATCC 51153™084535700832A9On the market[0447L] LYFO DISK™ S. pneumoniae ATCC 6305™084535700447A2On the market[0971L] LYFO DISK™ E. meningoseptica ATCC 13253™084535700971AQOn the market[0737P] KWIK-STIK™ C. glabrata ATCC 15126™084535700737AEOn the market[0533U] KWIK-STIK™ S. capitis ATCC 146™0845357005339UOn the marketNo certificate specifically references this device's Basic UDI-DI.