MACH 2 Mouse HRP-Polymer
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MACH 2 Mouse 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
- MHRP520MM EUDAMEDFDA UDIMHRP520L EUDAMEDFDA UDIMHRP520G EUDAMEDFDA UDIMHRP520H EUDAMEDFDA UDIMACH Mirco-Polymer Detection System for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627009388 EUDAMEDFDA UDI00847627009371 EUDAMEDFDA UDI00847627009357 EUDAMEDFDA UDI00847627009364 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
- Sweden EUDAMEDTürkiye EUDAMEDGermany EUDAMEDAustria 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 Mouse 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 (8)
- FDA UDI 4144ccb5-08dd-445c-8176-28e80c92cc1e 33 fields · synced Jul 17, 2026
- FDA UDI 5a166357-d8b3-4730-89a9-998605af212a 33 fields · synced May 25, 2026
- FDA UDI 77806c67-bd4e-4f2a-8a11-0d17b86b83cd 33 fields · synced May 30, 2026
- FDA UDI cab8a18e-b78b-4fc0-9438-a77f61e3c369 33 fields · synced May 30, 2026
- EUDAMED 001d0c1a-f449-4dc5-8c1d-07ca66301810 61 fields · synced Jul 9, 2026
- EUDAMED 4456267b-6e4d-4581-9e41-7e122a59ab70 61 fields · synced Jul 9, 2026
- EUDAMED 9f34e21c-fe43-478c-b6af-fffefe0aa7f8 61 fields · synced Jul 13, 2026
- EUDAMED cbc9571e-b68e-4588-be18-23a13996cc88 61 fields · synced Jul 17, 2026