MACH 2 Double Stain 2
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MACH 2 Double Stain 2 EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
- Device Name
- MACH Mirco-Polymer Detection System for IHC EUDAMED
- Model / Reference
- MRCT525L EUDAMEDFDA UDIMRCT525H EUDAMEDFDA UDIMRCT525G EUDAMEDFDA UDIMACH Mirco-Polymer Detection System for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627009449 EUDAMEDFDA UDI00847627009432 EUDAMEDFDA UDI00847627009425 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 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 Double Stain 2 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 14bbbd95-0f72-4569-8e83-ef7da9a726c8 33 fields · synced Jul 31, 2026
- FDA UDI 03058679-c9b0-4e66-bb7c-733b980592c7 33 fields · synced May 30, 2026
- FDA UDI bf185974-1796-4a36-8e92-0a0f8907c2cc 33 fields · synced May 30, 2026
- EUDAMED 60e94bcc-8438-453a-965e-0bdbcabc3e61 61 fields · synced Jul 22, 2026
- EUDAMED 4b610e04-e754-43f9-a7bd-006df247828f 61 fields · synced Jul 26, 2026
- EUDAMED fefc538d-7619-4e6b-bbfe-b5cd4e89eb20 61 fields · synced Jul 31, 2026