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EUDAMED last updated this device on Jun 26, 2026
084535700385A5[0385P] KWIK-STIK™ S. pyogenes (A) ATCC 19615™ 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.
20845357008507[0385P] KWIK-STIK™ S. pyogenes (A) ATCC 19615™(01)20845357008507
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01040601QC STRAINS BACTERIOLOGY1 warning recorded — scroll inside the panel to see all entries.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
US-MF-000000466The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
08453570013194On the market[0902K] KWIK-STIK™ S. Choleraesuis ATCC 10708™084535700902A5On the market[0647K] KWIK-STIK™ H. influenzae ATCC 49247™084535700647ACOn the market[0826K] KWIK-STIK™ S. abaetetuba SLR156084535700826AEOn the market[0520P] KWIK-STIK™ C. geochares ATCC 36852™0845357005209KOn the market[0333L] LYFO DISK™ P. laurentii ATCC 18803™0845357003339JOn the marketNo 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.