VDRL CONTROL SERUM KIT

GUDID B224V611

Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-syphilitic human sera for use with the VDRL slide flocculation test for detection of antibodies to Treponema pallidum. The kit contains: 5ml VDRL Reactive Control Serum 5ml VDRL Weakly Reactive Control Serum 5ml VDRL Nonreactive Control Serum Product Instructions

CENOGENICS CORPORATION

Treponema pallidum antigen IVD, control

• Primary Device ID: B224V611
• NIH Device Record Key: de7e8862-346b-47d8-b403-50bbb29b3860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VDRL CONTROL SERUM KIT
• Version Model Number: V-61
• Company DUNS: 068288943
• Company Name: CENOGENICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B224V611 [Primary]

FDA Product Code

• GMP: Antisera, Control For Nontreponemal Tests

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: 2021-06-04
• Device Publish Date: 2021-05-27

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• B224V611 - VDRL CONTROL SERUM KIT: 2021-06-04 Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-syphilitic human sera for use with the VDRL slide
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