Xpert Urine Specimen Collection Kit URINE/A-50

GUDID 07332940002954

Xpert Urine Specimen Collection Kit; 50 pack

CEPHEID

Sexually transmitted infection (STI) testing urine specimen collection kit IVD Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical

• Primary Device ID: 07332940002954
• NIH Device Record Key: 00dcc782-9353-4928-a7be-a21e19eaece8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert Urine Specimen Collection Kit
• Version Model Number: URINE/A-50
• Catalog Number: URINE/A-50
• 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: 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: 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
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940002954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173840

FDA Product Code

• LIO: Device, Specimen Collection

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: 2018-08-02
• Device Publish Date: 2018-07-02

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