Xpert® SWAB/F-100

GUDID 07332940006457

Nasal Sample Collect Kit for Viruses

CEPHEID

General specimen collection kit IVD, clinical

• Primary Device ID: 07332940006457
• NIH Device Record Key: 68aaab21-206e-45f0-af8e-41039f42d294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert®
• Version Model Number: SWAB/F-100
• Catalog Number: SWAB/F-100
• Company DUNS: 956711444
• Company Name: CEPHEID
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940006457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171552

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2022-05-11
• Device Publish Date: 2022-05-03

On-Brand Devices [Xpert®]

• 07332940008345: Swab Specimen Collection Kit
• 07332940007072: Xpert Xpress MVP
• 07332940006457: Nasal Sample Collect Kit for Viruses
• 07332940007669: GBS LB XC
• 07332940007652: GBS LB XC