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intelliPATH™ Hematoxylin
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref IPCS5006G20Model Hematoxylin
Identity
- Trade Name
- intelliPATH™ Hematoxylin, 20mL EUDAMEDintelliPATH™ Hematoxylin FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Hematoxylin EUDAMED
- Model / Reference
- IPCS5006G20 EUDAMEDFDA UDIHematoxylin EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627014481 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BCHEMATH6 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA 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
intelliPATH™ 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 (2)
- FDA UDI 5fb79c60-924a-4672-ac86-005f6d004a00 33 fields · synced Jul 20, 2026
- EUDAMED 7e1eb024-eb39-46ca-b678-b6b634fddbea 61 fields · synced Jul 20, 2026