GenePOC™ Strep A 133674

GUDID 00628055344087

The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.

GenePoc Inc

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• Primary Device ID: 00628055344087
• NIH Device Record Key: f5d5927b-438d-433f-bb51-e30714dd1933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenePOC™ Strep A
• Version Model Number: 133674
• Catalog Number: 133674
• 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: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca
• Phone: 1-844-616-1544
• Email: service@genepoc.ca

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055344087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183366

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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: 2019-05-08
• Device Publish Date: 2019-04-30

Devices Manufactured by GenePoc Inc

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• 00628055344087 - GenePOC™ Strep A: 2019-05-08The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.
• 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: 2018-07-06 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