Identity
- Trade Name
- Chroma ATE EUDAMEDFDA UDI
- Generic Name
- Magnetic particle separation instrument IVD FDA UDI
- Device Name
- MagXtract 3200 Automated Nucleic Acid Extraction System EUDAMEDMagXtract 3200 Automated Nucleic Acid Extraction System The MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes. Product Use Limitations: The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments. FDA UDI
- Model / Reference
- MagXtract 3200 EUDAMEDFDA UDI
- Description
- MagXtract 3200 Automated Nucleic Acid Extraction System The MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes. Product Use Limitations: The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719889100010 EUDAMEDFDA UDI
- Basic UDI-DI
- 471988910MX3G EUDAMED
- Direct Marketing DI
- 04719889100010 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER EUDAMED
- GMDN Term
- Magnetic particle separation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Chroma ATE by Chroma Ate Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 471988910MX3G | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Chroma Ate Inc.
- EUDAMED SRN
- TW-MF-000019529
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 65c29452-f2a1-47ef-bcee-805666aa8543 61 fields · synced Jun 18, 2026
- FDA UDI d21164af-597f-4a3d-86b9-099a781c9eda 33 fields · synced May 30, 2026