- Physicians Office Resource

Cologuard QuARTS Assay Reagents - 100030

Device Description

A collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] in a clinical specimen, using a nucleic acid amplification technique [e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PHP

Device Name: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Device Class: 3

Physical State: The device may be intended for manual or automated assay preparation. It may include specimen collection and preparation kits or reagents, and may utilize an algorithm for result determination.

Definition: The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening.

Submission Type ID: 2

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The test uses bisulfite conversion of methylated DNA and polymerase chain reaction to detect methylation of specific DNA markers, and enzymatic detection is used to detect occult hemoglobin.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: human stool, blood, plasma

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00858637005048

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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