FDA.reportPublic FDA data

HSV 1 10 Well; 10 pk

Primary DI
00813545025700
Brand
HSV 1 10 Well; 10 pk
Company
SCIMEDX CORPORATION
Model
I-HV101X
Catalog number
I-HV101X
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K905608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905608000INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.1991-11-07GQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545025700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545025700008135450257008135450257000813545025700

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

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