FDA.reportPublic FDA data

NA

Primary DI
05056080500010
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R62251
Published
2016-09-24
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
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
K904167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904167000PATHODX HERPES TYPINGDiagnostic Products Corp.1990-12-13GQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080500010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080500010050560805000105056080500010

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401322295600ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
232600853
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500065NAR308550012016-09-24
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24

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
30014613330110ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330127ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330158ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330165ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330196ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330202ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613332954ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613332961ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613332978ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613332985ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613332992ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333005ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613333012ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
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