Maxwell® CSC Rapid ccfDNA Kit AS1580

GUDID 00849811081835

The Maxwell® CSC Rapid ccfDNA Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of circulating cell-free DNA from human plasma samples.

PROMEGA CORPORATION

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 00849811081835
• NIH Device Record Key: 2014a95a-3161-4cfb-b199-2cbd3002bece
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxwell® CSC Rapid ccfDNA Kit
• Version Model Number: AS1580
• Catalog Number: AS1580
• Company DUNS: 089855696
• Company Name: PROMEGA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 608-839-7919
• Email: techserv@promega.com
• Phone: 608-839-7919
• Email: techserv@promega.com
• Phone: 608-839-7919
• Email: techserv@promega.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849811081835 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-24
• Device Publish Date: 2026-02-16

Devices Manufactured by PROMEGA CORPORATION

• 00849811081835 - Maxwell® CSC Rapid ccfDNA Kit: 2026-02-24The Maxwell® CSC Rapid ccfDNA Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of circulating cell-free DNA from human plasma samples.
• 00849811081835 - Maxwell® CSC Rapid ccfDNA Kit: 2026-02-24 The Maxwell® CSC Rapid ccfDNA Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isol
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• 00849811075902 - QuantiFluor® Dx dsDNA System: 2023-08-23 The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample c
• 00849811066115 - Maxwell® CSC Genomic DNA Kit: 2023-06-20 The Maxwell® CSC Genomic DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isola
• 00849811069062 - Maxwell® CSC Pathogen Total Nucleic Acid Kit: 2023-06-20 The Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to per
• 00849811051340 - Maxwell® CSC Instrument: 2022-02-09 The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perf