DNA/RNA Shield Collection Tube with Swab (2mL)

GUDID 00850027600031

Specimen receptacle medical devices for molecular-based in vitro diagnostic applications. Many sample types can be collected with these swab collection tubes including from the mouth, nose, throat, and wherever a swab may be deemed appropriate per application.

Zymo Research Corp.

Oral/upper respiratory tract specimen collection kit

• Primary Device ID: 00850027600031
• NIH Device Record Key: e2eef171-1aae-4f8d-93e3-8f7140f67242
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DNA/RNA Shield Collection Tube with Swab (2mL)
• Version Model Number: R1109-E
• Company DUNS: 927045336
• Company Name: Zymo Research Corp.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027600031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202641

FDA Product Code

• QBD: Microbial Nucleic Acid Storage And Stabilization Device

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: 2022-03-09
• Device Publish Date: 2022-03-01

Devices Manufactured by Zymo Research Corp.

• 00850027600024 - DNA/RNA Shield Collection Tube with Swab (1mL): 2022-03-09 Specimen receptacle medical devices for molecular-based in vitro diagnostic applications. Many sample types can be collected wit
• 00850027600031 - DNA/RNA Shield Collection Tube with Swab (2mL): 2022-03-09Specimen receptacle medical devices for molecular-based in vitro diagnostic applications. Many sample types can be collected with these swab collection tubes including from the mouth, nose, throat, and wherever a swab may be deemed appropriate per application.
• 00850027600031 - DNA/RNA Shield Collection Tube with Swab (2mL): 2022-03-09 Specimen receptacle medical devices for molecular-based in vitro diagnostic applications. Many sample types can be collected wit