Identity
- Trade Name
- Maxwell® CSC DNA FFPE Kit EUDAMEDFDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Maxwell® CSC DNA FFPE Kit EUDAMEDThe Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of DNA from FFPE (formalin fixed, paraffin embedded) tissue samples. FDA UDI
- Model / Reference
- AS1350 EUDAMEDFDA UDI
- Description
- The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of DNA from FFPE (formalin fixed, paraffin embedded) tissue samples. FDA UDI
Identifiers
- Catalog Number
- AS1350 FDA UDI
- Primary DI / UDI-DI
- 00849811051753 EUDAMEDFDA UDI
- Basic UDI-DI
- 08498110517532X EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02060185 ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
Maxwell® CSC DNA FFPE Kit by Promega Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 a4ef2ee6-369d-4a9c-9f25-8079b7d20705 36 fields · synced Jun 19, 2026
- EUDAMED 05949b2b-c2a6-4cd3-b34e-2f5343c66546 61 fields · synced Jun 19, 2026