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EUDAMED last updated this device on Apr 23, 2026
B-00628448120083Labex Canada is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Labex Canada Inc.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00628448120083LCR-0060-06(01)00628448120083
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030709PRIMARY ANTISERA FOR IMMUNOHISTOLOGY1 warning recorded — scroll inside the panel to see all entries.
1. For in vitro diagnostic (IVD) use. 2. Materials of human or animal origin should be handled as biohazardous materials and disposed of with proper precautions. 3. Avoid contact of reagents with eyes, skin, and mucous membranes. Use protective clothing and gloves. If reagents come in contact with sensitive areas, wash with copious amounts of water. 4. Avoid microbial contamination of reagents as it may interfere with the results. 5. Consult local and/or state authorities in regards to recommended method of disposal. 6. Do not use product beyond the expiration date. 7. This reagent contains ProClin 300. Pregnant women and children under 18 years age should avoid contact with the reagents. If contact happens, wash with copious amounts of water.
Primary placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | — | Still on market |
CA-MF-000039965Sterile
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 →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.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.