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Polyclonal Rabbit Anti-Mouse Immunoglobulins/ RPE, Rabbit F(ab')2
EUDAMEDClass A (EU MDR)
Ref R0439Model F031302-2
Identity
- Trade Name
- Polyclonal Rabbit Anti-Mouse Immunoglobulins/ RPE, Rabbit F(ab')2 EUDAMED
- Device Name
- Polyclonal Rabbit Anti-Mouse Immunoglobulins/FITC Rabbit F(ab')2 EUDAMED
- Model / Reference
- F031302-2 EUDAMEDR0439 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572008194 EUDAMED
- Basic UDI-DI
- 570057R0302P3006A017201MJ EUDAMED
- EMDN Code
- W0103080599 AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
Polyclonal Rabbit Anti-Mouse Immunoglobulins/ RPE, Rabbit F(ab')2 by Agilent Technologies Singapore (International) Pte Ltd — Class A — IVDR — listed in EUDAMED
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 | 570057R0302P3006A017201MJ | Class A | Active |
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Manufacturer
- EUDAMED SRN
- SG-MF-000014448
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED ae4a2cdf-5dfe-4661-9464-b1a301d7e3b8 61 fields · synced Oct 6, 2026