intelliPATH FLX™ Peroxidase Blocking Reagent
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- intelliPATH FLX™ Peroxidase Blocking Reagent EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry endogenous enzyme blocking reagent IVD FDA UDI
- Device Name
- Peroxidazed 1 EUDAMED
- Model / Reference
- IPB5000L EUDAMEDFDA UDIPeroxidase Blocking Reagents EUDAMEDIPB5000G20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627008817 EUDAMEDFDA UDI00847627008800 FDA UDI
- Basic UDI-DI
- 08476270BPERBLKRZ9 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry endogenous enzyme blocking reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Spain 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 endogenous enzyme blocking reagent IVD
intelliPATH FLX™ Peroxidase Blocking Reagent by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Immunohistochemistry endogenous enzyme blocking reagent IVD.
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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 (3)
- FDA UDI 4fef82ad-20b7-41cb-916d-0d2ae0940788 33 fields · synced Jul 9, 2026
- FDA UDI e4f4aa41-3a3e-4cb8-a404-0c9caccc5411 33 fields · synced May 30, 2026
- EUDAMED eb807197-43b3-4291-86e3-91e88e12fb6c 61 fields · synced Jul 9, 2026