Maxwell® CSC Pathogen Total Nucleic Acid Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Maxwell® CSC Pathogen Total Nucleic Acid Kit EUDAMEDFDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Maxwell® CSC Pathogen Total Nucleic Acid Kit EUDAMEDThe Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of pathogen total nucleic acid from human samples. FDA UDI
- Model / Reference
- AS1860 EUDAMEDFDA UDI
- Description
- The Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of pathogen total nucleic acid from human samples. FDA UDI
Identifiers
- Catalog Number
- AS1860 FDA UDI
- Primary DI / UDI-DI
- 00849811069062 EUDAMEDFDA UDI
- Basic UDI-DI
- 08498110690623Y 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nucleic acid extraction/isolation kit IVD
Maxwell® CSC Pathogen Total Nucleic Acid Kit by Promega Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Promega Corporation
Sources (2)
- FDA UDI bfdce8ab-9711-4c90-9688-133f8cc53670 36 fields · synced Jul 12, 2026
- EUDAMED 9170b573-d7f8-4be6-8e41-bcb8eba71b05 61 fields · synced Jul 12, 2026