GenePOC™ CDiff 132994

GUDID 00628055344025

The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI.

GenePoc Inc

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00628055344025
• NIH Device Record Key: 63872285-59bb-45f5-8ff7-5e9d95c2f4fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenePOC™ CDiff
• Version Model Number: 132994
• Catalog Number: 132994
• Company DUNS: 202672846
• Company Name: GenePoc Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com
• Phone: 1-844-616-1544
• Email: fran@mdcassoc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055344025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172569

FDA Product Code

• OZN: C.Difficile Toxin Gene Amplification Assay

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-29

Devices Manufactured by GenePoc Inc

• 00628055344070 - GenePOC™ Carba: 2019-06-03 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the
• 00628055344087 - GenePOC™ Strep A: 2019-05-08 The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that util
• 00628055344001 - revogene™: 2018-07-06 The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assa
• 00628055344018 - GenePOC™ GBS LB: 2018-07-06 The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect
• 00628055344025 - GenePOC™ CDiff: 2018-07-06The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI.
• 00628055344025 - GenePOC™ CDiff: 2018-07-06 The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes autom
• 00628055344032 - MOCK PIE: 2018-07-06 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE