Maxwell® CSC Instrument

FDA UDIEUDAMED

Class I (US FDA UDI)

by Promega Corporation

Identity

Trade Name: Maxwell® CSC Instrument FDA UDI
Generic Name: Magnetic particle separation instrument IVD FDA UDI
Device Name: The Maxwell® CSC 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: AS6000 FDA UDI
Description: The Maxwell® CSC 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: AS6000 FDA UDI
Primary DI / UDI-DI: 00849811051340 FDA UDI
FDA Product Code: JJH FDA UDI
GMDN Term: Magnetic particle separation instrument IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Magnetic particle separation instrument IVD

Maxwell® CSC 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.

Macro & Micro-Test Automatic Nucleic Acid Extractor — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
T2Dx® — T2biosystems, Inc. · Class II
Maxwell® CSC 48 Instrument — Promega Corporation · Class I

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 54d38f64-a761-4701-acec-137dff6fd091 35 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026