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 Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control Treponema pallidum antigen IVD, control
Primary Device IDB224V611
NIH Device Record Keyde7e8862-346b-47d8-b403-50bbb29b3860
Commercial Distribution StatusIn Commercial Distribution
Brand NameVDRL CONTROL SERUM KIT
Version Model NumberV-61
Company DUNS068288943
Company NameCENOGENICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB224V611 [Primary]

FDA Product Code

GMPAntisera, Control For Nontreponemal Tests

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-04
Device Publish Date2021-05-27

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B224V611 - VDRL CONTROL SERUM KIT2021-06-04Cenogenics 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
B224V611 - VDRL CONTROL SERUM KIT2021-06-04 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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