Home GUDID B224V611 VDRL CONTROL SERUM KIT
Primary DI B224V611
Brand VDRL CONTROL SERUM KIT
Company CENOGENICS CORPORATION
Model V-61
Device description 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
Published 2021-05-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name GMP Antisera, Control For Nontreponemal Tests
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMP Antisera, Control For Nontreponemal Tests Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B224V611 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Treponema pallidum antigen IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Treponema pallidum bacteria in a clinical specimen.
Regulatory Flags# DUNS number 068288943 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B224SB191 TRI-SLIDE PATIENT ENVELOPE KIT SB-19 SB-19 2021-05-27 B224SB201 TRI-SLIDE STOOL BLOOD TEST SB-20 SB-20 2021-05-27 B224SB211 PROFESSIONAL SINGLE SLIDE KIT SB-21 SB-21 2021-05-27 B224R201 RF LATEX Test Kit R-20 R-20 2021-05-27 B224V551 VDRL Antigen Kit V-55 V-55 2016-10-17
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