EDTA Decloaker 5X
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- EDTA Decloaker, 5X EUDAMEDEDTA Decloaker 5X FDA UDI
- Generic Name
- Immunohistochemistry antigen retrieval reagent IVD FDA UDI
- Device Name
- Antigen Retrieval Reagent for IHC EUDAMED
- Model / Reference
- CB917L EUDAMEDFDA UDICB917M EUDAMEDFDA UDIAntigen Retrieval Reagents for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627014306 EUDAMEDFDA UDI00847627014313 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
- Sweden 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
EDTA Decloaker 5X 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 (4)
- FDA UDI adb833cb-7b0b-471c-8ace-c1058d967578 33 fields · synced Sep 18, 2026
- FDA UDI 7a35d944-5564-4728-a0b8-cde0ce3f38c7 33 fields · synced May 30, 2026
- EUDAMED 90eeb3b3-37f4-42cd-9704-e4a0c98a975d 61 fields · synced Jul 20, 2026
- EUDAMED 34ed2979-5ca6-4c48-8b8a-d9c6340962ed 61 fields · synced Sep 18, 2026