VDRL Antigen Kit V-55

GUDID B224V551

VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infecti

CENOGENICS CORPORATION

Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device IDB224V551
NIH Device Record Keyfeed8fb9-b765-4da9-ac62-de04185df9a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVDRL Antigen Kit
Version Model NumberV-55
Catalog NumberV-55
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

Customer Support Contacts

Phone(732) 536-6457
Emailcenogenics@verizon.net
Phone(732) 536-6457
Emailcenogenics@verizon.net

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB224V551 [Primary]

FDA Product Code

GMQAntigens, Nontreponemal, All

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-17

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