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ONCORE Pro Hematoxylin
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OPRI6050T60Model MACH Mirco-Polymer Detection System for IHCRef OPRI6087T60Model Hematoxylin
Identity
- Trade Name
- Mouse Amp HRP Detection EUDAMEDFDA UDIMouse HRP Detection EUDAMEDONCORE Pro Hematoxylin FDA UDI
- Generic Name
- Biological stain IVD FDA UDIPolymer-enzyme conjugate IVD, reagent FDA UDI
- Device Name
- MACH Mirco-Polymer Detection System for IHC EUDAMEDHematoxylin EUDAMED
- Model / Reference
- OPRI6087T60 EUDAMEDFDA UDIOPRI6050T60 EUDAMEDFDA UDIMACH Mirco-Polymer Detection System for IHC EUDAMEDHematoxylin EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627034830 EUDAMEDFDA UDI00847627031914 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BMACH421JC EUDAMED08476270BCHEMATH6 EUDAMED
- FDA Product Code
- HYJ FDA UDINJT FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMEDW01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Biological stain IVD FDA UDIPolymer-enzyme conjugate IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI864.1860 FDA UDI
- Market of Registration
- Italy EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Prescription Use
No
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological stain IVD
ONCORE Pro Hematoxylin by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (4)
- FDA UDI 37034a71-f95c-4590-854c-7e4293888e8e 33 fields · synced Jul 18, 2026
- FDA UDI 6a3f0768-d499-49ad-bf2e-465f7c21f4c8 33 fields · synced May 24, 2026
- EUDAMED c5166475-5aef-458f-87d9-f15468e0f63e 61 fields · synced Jul 14, 2026
- EUDAMED 840dbdef-6fff-40fc-b924-668e578e9e1e 61 fields · synced Jul 18, 2026