Reveal Decloaker RTU
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Reveal Decloaker, RTU EUDAMEDReveal Decloaker RTU FDA UDI
- Generic Name
- Immunohistochemistry antigen retrieval reagent IVD FDA UDI
- Device Name
- Antigen Retrieval Reagent for IHC EUDAMED
- Model / Reference
- RV1000MMRTU EUDAMEDFDA UDIAntigen Retrieval Reagents for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627014597 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BAGRETFS EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry antigen retrieval reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunohistochemistry antigen retrieval reagent IVD
Reveal Decloaker RTU 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
IVDR
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 abef7a24-6934-471e-a5f9-f9059cf086a4 33 fields · synced Aug 3, 2026
- EUDAMED b2771e45-804a-4ff9-ba80-1b82c7faf5da 61 fields · synced Aug 3, 2026