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PolyTek Anti-Mouse HRP Polymer (DAB) Large Volume Kit 50 mL
EUDAMEDClass A (EU MDR)
Ref PIR050
Identity
- Trade Name
- PolyTek Anti-Mouse HRP Polymer (DAB) Large Volume Kit 50 mL EUDAMED
- Device Name
- Immunohistology Kits EUDAMED
- Model / Reference
- PIR050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108717614 EUDAMED
- Basic UDI-DI
- 081010871W01030711F5 EUDAMED
- Direct Marketing DI
- 00810108717614 EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
PolyTek Anti-Mouse HRP Polymer (DAB) Large Volume Kit 50 mL by ScyTek Laboratories Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081010871W01030711F5 | Class A | Active |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 7cf3f33d-8557-4e98-8ac2-5c3e51d84e28 61 fields · synced Jul 18, 2026