FDA.reportPublic FDA data

MicroTrak®

Primary DI
05391516748643
Brand
MicroTrak®
Company
TRINITY BIOTECH PUBLIC LIMITED COMPANY
Model
8H329UL
Catalog number
8H329UL
Device description
MicroTrak® HSV 1 /HSV 2 Direct Specimen - Collection Kit
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850739000AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECTSyva Co.1985-03-11GQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516746137PackageGS120Not in Commercial Distribution
05391516748643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746137053915167461375391516746137
05391516748643053915167486435391516748643

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a fluorescent immunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+35312769800Infectiousdisease.techsupport@trinitybiotech.com

Regulatory Flags#

DUNS number
988298840
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516741927Trinity Biotech450-A450-A2016-09-23
05391516742238Trinity Biotech591-C591-C2017-10-06
05391516742245Trinity Biotech591-D 591-D 2017-10-06
05391516746106Uni-Gold™ 120650612065062016-09-23
05391516746113Uni-Gold™ 120653012065302016-09-23
05391516742290Trinity Biotech 826-10826-102016-09-23
05391516745161Bartels®B1029-81AB1029-81A2016-09-23
05391516745826Bartels®B1029-44B1029-442016-09-23
05391516745864Bartels® B1029-44CB1029-44C2016-09-23
05391516745871Bartels®B1029-81B1029-812016-09-23
05391516745888Bartels®B1029-81BB1029-81B2016-09-23
05391516745901Bartels®B1029-91B1029-912016-09-23
05391516745918Bartels®B1029-47B1029-472016-09-23
05391516745925Bartels®B1029-47CB1029-47C2016-09-23
05391516745932Bartels®B1029-48B1029-482016-09-23
05391516745949Bartels® B1029-47BB1029-47B2016-09-23
05391516746007MicroTrak®8H219UL8H219UL2016-09-23
05391516746038MicroTrak®8H349UL 8H349UL 2016-09-23
05391516746144MicroTrak®8H399UL8H399UL2016-09-23
05391516741521Trinity Biotech203-A203-A2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229025001Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 TestHemagen Diagnostics, Inc.GQL2023-10-05
G5229025011Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only KitHemagen Diagnostics, Inc.GQL2023-10-05
G522902600Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 TestHemagen Diagnostics, Inc.GQL2023-10-05
G5229026011Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only KitHemagen Diagnostics, Inc.GQL2023-10-05
04053252278679Light Diagnostics HSV 1 & 2 Control Slides (5 Pack)EMD Millipore CorporationGQL2020-04-16
04053252670930Light Diagnostics HSV 2 Typing ReagentEMD Millipore CorporationGQL2020-04-16
04053252678257Light Diagnostics HSV 1 Typing ReagentEMD Millipore CorporationGQL2020-04-16
04061841047469Light Diagnostics HSV 1 & 2 Control SlideEMD Millipore CorporationGQL2020-04-16
30014613336013ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-04-02
30014613336020ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-04-02
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30014613333029ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333036ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333043ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333050ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333067ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333074ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333081ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07