FDA.reportPublic FDA data

HSV 1&2 ELITe MGB Assay for CE-IVD

Primary DI
03661540951947
Brand
HSV 1&2 ELITe MGB Assay for CE-IVD
Company
Elitechgroup Mdx LLC
Model
RTK403ING
Catalog number
RTK403ING
Device description
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.
Published
2020-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540951947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540951947036615409519473661540951947

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-453-2725MDx@elitechgroup.com

Regulatory Flags#

DUNS number
117458512
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

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03661540953149DSQ Alert® HT Pneumocystis jirovecii Primer Mix M800849M8008492026-05-12
03661540953156DSQ Alert® HT Pneumocystis jirovecii Probe MixM800850M8008502026-05-12
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnM800845M8008452026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnM800846M8008462026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnM800847M8008472026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnM800848M8008482026-03-24
03661540952722DSQ Alert HHV7 Primer Mix ASRM800766M8007662025-10-14
03661540952739DSQ Alert HHV7 Probe Mix ASRM800767M8007672025-10-14
03661540950001MRSA/SA ELITe MGBM8003462016-10-13
03661540951411MGB Alert Internal Control Set IC2-480 rxn8003628003622020-09-15
03661540951862MGB Alert®Internal Control 1C Set, 480 rxn8003618003612020-09-15
03661540951336MGB Alert HHV-6 Primer Mix ASR - 480 rxn8003388003382020-09-14
03661540951770MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions8004348004342020-09-08
03661540952906MGB Alert® HDV Primer Mix ASRM800817M8008172025-10-15
03661540952913MGB Alert HDV Probe Mix ASRM800818M8008182025-10-15
03661540952517MGB Alert 2X ELITaq Master Mix, 48rxnM800809M8008092023-02-03
03661540952524MGB Alert ELITaq Master Mix, 480 rxnM800810M8008102023-02-03
03661540950278MGB Alert Platinum Master Mix-48 rxnM800599M8005992020-09-15
03661540951725MGB Alert 2X PCR Master Mix 480 rxnM800547M8005472020-09-15
03661540951756MGB Alert One-Step Reverse Transcriptase PCR Master Mix M800689M8006892020-09-15

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