MACH 2 Rabbit HRP-Polymer
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MACH 2 Rabbit HRP-Polymer EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
- Device Name
- MACH Mirco-Polymer Detection System for IHC EUDAMED
- Model / Reference
- RHRP520L EUDAMEDFDA UDIRHRP520MM EUDAMEDFDA UDIRHRP520G EUDAMEDFDA UDIMACH Mirco-Polymer Detection System for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627012517 EUDAMEDFDA UDI00847627012524 EUDAMEDFDA UDI00847627012494 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BMACH421JC EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Austria EUDAMEDItaly EUDAMEDSweden 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 antibody detection IVD, reagent
MACH 2 Rabbit HRP-Polymer 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 (6)
- FDA UDI 2d113708-fb0d-40f9-9950-deb860f57f0e 33 fields · synced Aug 3, 2026
- FDA UDI f3c8a72f-0874-41b9-97d7-829bd1bc18a3 33 fields · synced May 24, 2026
- FDA UDI 0e7e14fe-a3db-4862-837a-c746c8463b7b 33 fields · synced May 30, 2026
- EUDAMED 9c1c55f6-6e8b-43ca-a17f-c9ee9b8c4ff2 61 fields · synced Jul 17, 2026
- EUDAMED d6bd18d1-0bd2-4ff1-a313-9b3e72641d99 61 fields · synced Jul 28, 2026
- EUDAMED a11120d3-55b0-46d0-a57b-e01357082d48 61 fields · synced Aug 3, 2026