MACH 3 Rabbit HRP Polymer Detection
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Rabbit HRP Detection EUDAMEDFDA UDIMACH 3 Rabbit HRP-Polymer Detection EUDAMEDMACH 3 Rabbit HRP Polymer Detection FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDIPolymer-enzyme conjugate IVD, reagent FDA UDI
- Device Name
- MACH Mirco-Polymer Detection System for IHC EUDAMED
- Model / Reference
- M3R531H EUDAMEDFDA UDIM3R531L EUDAMEDFDA UDIOPRI6008T60 EUDAMEDFDA UDIMACH Mirco-Polymer Detection System for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627030665 EUDAMEDFDA UDI00847627030672 EUDAMEDFDA UDI00847627031884 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BMACH421JC EUDAMED
- FDA Product Code
- PPM FDA UDINJT FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDIPolymer-enzyme conjugate IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI864.1860 FDA UDI
- Market of Registration
- Sweden EUDAMEDItaly 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, kit, enzyme immunohistochemistry
MACH 3 Rabbit HRP Polymer Detection 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 303dcde5-9d39-422c-9d8c-0c5948a8f1b9 33 fields · synced Jul 29, 2026
- FDA UDI 906e95bc-c36d-49bc-bddc-98f2c4a7d68c 33 fields · synced May 30, 2026
- FDA UDI 2a535a63-5bb3-4329-8100-f6b9ddec5a68 33 fields · synced May 30, 2026
- EUDAMED 8bc03d4a-bc19-4db3-ba3f-4d255f35ea5b 61 fields · synced Jul 9, 2026
- EUDAMED 22bf5ecd-2939-447a-8fe2-9d44c1dceedc 61 fields · synced Jul 13, 2026
- EUDAMED 4dded5ad-b75a-42a0-a083-cfc7cf3dc73a 61 fields · synced Jul 29, 2026