HSV 1&2 ELITe MGB Assay for CE-IVD RTK403ING

GUDID 03661540951947

The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection.

ELITECH GROUP INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Primary Device ID03661540951947
NIH Device Record Key05c91df0-f11e-4dd6-bae7-d58f3f885b38
Commercial Distribution StatusIn Commercial Distribution
Brand NameHSV 1&2 ELITe MGB Assay for CE-IVD
Version Model NumberRTK403ING
Catalog NumberRTK403ING
Company DUNS079696864
Company NameELITECH GROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540951947 [Primary]

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-23
Device Publish Date2020-09-15

Devices Manufactured by ELITECH GROUP INC.

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