Identity
- Trade Name
- Maxwell® CSC 48 Instrument EUDAMEDFDA UDI
- Generic Name
- Magnetic particle separation instrument IVD FDA UDI
- Device Name
- Maxwell® CSC 48 Instrument EUDAMEDThe Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples. FDA UDI
- Model / Reference
- AS8000 EUDAMEDFDA UDI
- Description
- The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples. FDA UDI
Identifiers
- Catalog Number
- AS8000 FDA UDI
- Primary DI / UDI-DI
- 00849811060991 EUDAMEDFDA UDI
- Basic UDI-DI
- 08498110609913M EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02060180 ROBOTIC SAMPLE PROCESSING SYSTEMS - HARDWARE ACCESSORIES 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
- Germany 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
Category: Magnetic particle separation instrument IVD
Maxwell® CSC 48 Instrument by Promega Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Magnetic particle separation instrument IVD.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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
- Promega Corporation
Sources (2)
- FDA UDI 1a077ce9-b04f-4e59-b192-5413578b2829 35 fields · synced Jul 19, 2026
- EUDAMED 225a79a4-6fc4-40ef-8c3e-2509e9555167 61 fields · synced Jul 19, 2026