OMNIgene GUT Dx

GUDID 00627595000774

Microbial DNA Collection and Stabilization, Human Fecal Samples

DNA Genotek Inc

Faecal specimen container IVD, DNA preservation solution

• Primary Device ID: 00627595000774
• NIH Device Record Key: 0f59a49a-b32d-435b-8eb0-da390816e1f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNIgene GUT Dx
• Version Model Number: OMD-200
• Company DUNS: 207983508
• Company Name: DNA Genotek 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: false
• 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: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627595000507 [Primary]
GS1	00627595000774 [Package]; Contains: 00627595000507; Package: OMD-200+ACP123 [1 Units]; In Commercial Distribution
GS1	10627595000504 [Package]; Contains: 00627595000507; Package: Reclosable Bag [25 Units]; In Commercial Distribution
GS1	10627595001426 [Package]; Contains: 00627595000507; Package: MP-016 [1 Units]; In Commercial Distribution
GS1	10627595001433 [Package]; Contains: 00627595000507; Package: SOF-1020 [1 Units]; In Commercial Distribution
GS1	10627595001464 [Package]; Contains: 00627595000507; Package: MP-020 [1 Units]; In Commercial Distribution
GS1	10627595001471 [Package]; Contains: 00627595000507; Package: SOF-1025 [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200040

FDA Product Code

• QPO: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

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: 2022-11-28
• Device Publish Date: 2022-11-18

Devices Manufactured by DNA Genotek Inc

• 00627595000682 - Accessory Sponges: 2022-11-29 DNA Assisted Collection, Sponges
• 10627595000313 - ORAcollect Dx: 2022-11-28 DNA Specimen Collection, Saliva
• 00627595000415 - PrepIT L2P: 2022-11-28 DNA Preparation Kit, 5 ml
• 00627595000422 - PrepIT L2P: 2022-11-28 DNA Preparation Kit, 45 ml
• 00627595000774 - OMNIgene GUT Dx: 2022-11-28Microbial DNA Collection and Stabilization, Human Fecal Samples
• 00627595000774 - OMNIgene GUT Dx: 2022-11-28 Microbial DNA Collection and Stabilization, Human Fecal Samples
• 00627595000545 - OMNIgene Liquefaction Reagent: 2022-11-28 Microbial DNA Stool Sample Processing, Reagent 200mL
• 00627595000552 - OMNIgene Liquefaction Reagent: 2022-11-28 Microbial DNA Stool Sample Processing, Reagent 800mL
• 10627595001136 - OMNIgene ORAL: 2022-11-28 Nucleic Acids Specimen Collection and Stabilization, Saliva.