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DS Enzyme Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OPRI6060KT60Model Enzyme Retrieval Reagents for IHC
Identity
- Trade Name
- DS Enzyme Kit EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry protease reagent IVD FDA UDI
- Device Name
- Enzyme Retrieval Reagents for IHC EUDAMED
- Model / Reference
- OPRI6060KT60 EUDAMEDFDA UDIEnzyme Retrieval Reagents for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627025098 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BENZRETRS EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry protease reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 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
Yes
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: Immunohistochemistry protease reagent IVD
DS Enzyme Kit 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 78a34872-b6bb-4f06-8c2e-a5a2caf3773d 33 fields · synced Jun 19, 2026
- EUDAMED ade91b60-4c97-48aa-8cc0-184f38479635 61 fields · synced Jun 19, 2026