VERSANT HCV Control 2.0 Kit (LiPA) 10719668

GUDID 00630414000510

VERSANT HCV Control 2.0 Kit

Siemens Healthcare Diagnostics Inc.

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00630414000510
• NIH Device Record Key: b9ce7405-43d3-4b60-8348-1532c4103019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSANT HCV Control 2.0 Kit (LiPA)
• Version Model Number: 10719668
• Catalog Number: 10719668
• Company DUNS: 064608573
• Company Name: Siemens Healthcare 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: false
• 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: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414000510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160016

FDA Product Code

• OBF: Assay, genotyping, hepatitis c virus

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-15

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