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CAT Hematoxylin
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref CATHE-MMModel Hematoxylin
Identity
- Trade Name
- CAT Hematoxylin, 1000mL EUDAMEDCAT Hematoxylin FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Hematoxylin EUDAMED
- Model / Reference
- CATHE-MM EUDAMEDFDA UDIHematoxylin EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627014276 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BCHEMATH6 EUDAMED
- FDA Product Code
- HYJ 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
- 864.1850 FDA UDI
- Market of Registration
- Italy 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
CAT 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 04e52ab4-1643-4452-826d-7a2bb58f8032 33 fields · synced Jul 30, 2026
- EUDAMED 3b081235-bfe0-4210-8c63-caec7034e1de 61 fields · synced Jul 30, 2026