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Dewax Solution Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OPRI6004KT60 Model Dewaxing Reagents of IHC
Identity
- Trade Name
- Dewax Solution Kit EUDAMEDFDA UDI
- Generic Name
- Dewaxing solution IVD FDA UDI
- Device Name
- Dewax Solution Kit EUDAMED
- Model / Reference
- OPRI6004KT60 EUDAMEDFDA UDIDewaxing Reagents of IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627031846 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BDEWAXH2 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Dewaxing solution 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: Dewaxing solution IVD
Dewax Solution Kit by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dewaxing solution IVD.
- TintoDewaxer, 1L — BIO SB, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Hot Rinse 25X — BIOCARE MEDICAL, LLC · Class I
- ONCORE Pro ISH Dewax Kit — BIOCARE MEDICAL, LLC · Class I
- Aqua DePar 10X — BIOCARE MEDICAL, LLC · Class I
- Dewax Solution 2, DS2 Kit — BIOCARE MEDICAL, LLC · Class I
- Dewax Solution 1, DS1 — BIOCARE MEDICAL, LLC · Class I
- Slide Brite — BIOCARE MEDICAL, LLC · Class I
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 568781e3-7172-4493-a299-2e79c5f76b5e 33 fields · synced Jul 23, 2026
- EUDAMED caaf9500-89fa-452a-822f-50b5cfc0feb2 61 fields · synced Jul 23, 2026