Synovasure® Alpha Defensin 00-8888-125-10

GUDID 00887868540677

CD DIAGNOSTICS, INC.

Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00887868540677
• NIH Device Record Key: a907c2d7-4f82-49da-be29-fe05eb44cf07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synovasure® Alpha Defensin
• Version Model Number: 00-8888-125-10
• Catalog Number: 00-8888-125-10
• Company DUNS: 027871090
• Company Name: CD DIAGNOSTICS, 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: true
• 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(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868540677 [Primary]
GS1	70887868540676 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN180032

FDA Product Code

• QGN: Lateral flow immunochromatography assay for host infection biomarkers

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

[00887868540677]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-14
• Device Publish Date: 2022-02-04

On-Brand Devices [Synovasure® Alpha Defensin]

• 00887868540691: 00-8888-125-02
• 00887868540684: 00-8888-125-30
• 00887868540677: 00-8888-125-10
• 00887868540653: 00-8888-125-01
• 70887868540669: 00-8888-125-05