FDA.reportPublic FDA data

Pathfinder

Primary DI
00847865001472
Brand
Pathfinder
Company
Bio-RAD Laboratories, Inc.
Model
30491
Catalog number
30491
Device description
HSV Type 2 Monoclonal Antibody
Published
2016-09-12
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
K852125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852125000PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMPKallestad Laboratories, Inc.1985-07-30GQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865001472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865001472008478650014728478650014720847865001472

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport.USSD-Redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

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