HSV 2 10 Well; 10 pk I-HV201X

GUDID 00813545025731

SCIMEDX CORPORATION

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Primary Device ID00813545025731
NIH Device Record Keya934df7b-1430-484c-aea5-ed9976e4b40a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHSV 2 10 Well; 10 pk
Version Model NumberI-HV201X
Catalog NumberI-HV201X
Company DUNS155424708
Company NameSCIMEDX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813545025731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

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